Safety
Enforcement Report for June 13, 2012
"As part of FDA's efforts to increase the transparency of its compliance and enforcement data, FDA will soon be introducing a very different Enforcement Report format aiming to deliver a simpler, clearer report that encourages data download and analyses while also providing savings and encouraging future innovation for Government. Instead of the narrative report you see now, you will find a data-driven report encouraging innovative stakeholders to extract more intelligence out of the data and providing FDA a baseline as it moves forward in its efforts to integrate the Agency's compliance and enforcement data.
We expect to publish the new report mid-June. This will not be the first and only iteration of the report. We want your feedback - the good, the bad, and the ugly. So please be on the lookout for the new report and e-mail us at webmail@oc.fda.gov with your comments."
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
PRODUCT
1) Turkey & Ham Footlong. Products are labeled in part: "***Anytime Deli Turkey & Ham FOOTLONG*** XX/XX/12***LOT #***KEEP REFRIGERATED***ALLERGENS: Wheat, Soy, Egg, and Milk***HAM AND TURKEY FOOTLONG*** 7 05432 00194 5***KEEP REFRIGERATED***Total Weight: 12.20 oz-wt. ((345.87g)***". "***Sandwich Central***Sandwiches Hot Dogs & More***Turkey & Ham FOOTLONG***xx/xx/12***LOT #***KEEP REFRIGERATED***ALLERGENS: Wheat, Soy, Egg, and Milk***HAM AND TURKEY FOOTLONG*** 7 05432 00194 5***KEEP REFRIGERATED***Total Weight: 12.20 oz-wt. ((345.87g)***". Recall # F-1336-2012;
2) Italian Footlong. Product is labeled in part: "***Anytime Deli***Italian***FOOTLONG***XX/XX/12***LOT #***KEEP REFRIGERATED***"***ALLERGENS: Wheat, Soy, and Milk***ITALIAN FOOTLONG***7 05432 00196 9***KEEP REFRIGERATED***Total Weight: 11.60 oz-wt. ((328.8G)***". "***Sandwich Central***Sandwiches Hot Dogs and More***Italian FOOTLONG***XX/XX/12***LOT #***KEEP REFRIGERATED***ALLERGENS: Wheat, Soy, and Milk***ITALIAN FOOTLONG***7 05432 00196 9***KEEP REFRIGERATED***Total Weight: 11.60 oz-wt. ((328.8G). Recall # F-1337-2012;
3) Classic Cuban sandwich. The product was labeled in part: Primary Label: "***Dandee***CLASSIC CUBAN***on Authentic Cuban Bread***Since 1956***ALLERGENS: Wheat, Soy, Egg, and Milk***7 05432 00156 3***CLASSIC CUBAN KEEP REFRIGERATED***Total Weight 8.45 oz-wt. (239.56g)***UPC 0543200156. Recall # F-1338-2012
CODE
Expiration dates from 01/19/2012 through 05/02/2012 and lot number from 00112 through 10412
RECALLING FIRM/MANUFACTURER
M.E. Thompson Inc., Jacksonville, FL, by press release, letters, email, telephone and visit beginning April 17, 2012. Florida initiated Recall is ongoing.
REASON
The products have the potential to be adulterated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
529,327 units
DISTRIBUTION
Nationwide
PRODUCT
1) Harris Teeter Traders brand Lemon Sorbet, Pints, Net Wt 16 fl oz. (473 ml), UPC # 7203698196. Recall # F-1345-2012;
2) Harris Teeter Traders brand Raspberry Sorbet, Pints, Net Wt 16 fl.oz. (473 ml), UPC # 7203698195. Recall # F-1346-2012;
3) Harris Teeter Traders brand Mango Sorbet, Pints, Net Wt 16 fl.oz. (473 ml), UPC # 7203698194. Recall # F-1347-2012;
4) Harris Teeter Traders brand Coconut Sorbet, Pints, Net Wt 16 fl.oz. (473 ml), UPC # 7203698197. Recall # F-1348-2012;
5) Harris Teeter Traders brand Blood Orange Sorbet, Pints, Net Wt 16 fl.oz. (473 ml), UPC # 7203698193. Recall # F-1349-2012
CODE
1) - 5) Lot #030813
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harris Teeter Distribution Center, Greensboro, NC, by email on May 21, 2012 and by press release on May 22, 2012.
Manufacturer: Harris Teeter Inc., d/b/a Hunter Farms, High Point, NC. Firm initiated recall is ongoing.
REASON
Product contains undeclared allergen (milk).
VOLUME OF PRODUCT IN COMMERCE
24,264 units
DISTRIBUTION
NC
PRODUCT
CHIVES --- The Chives were distributed in plastic clamshell containers 0.25 oz. (UPC 0 21985 20005 6) and 2/3 oz. (UPC 0 21985 10004 2), in 1 lb. bags, and 1/2 oz. twist tie bunches. Recall # F-1350-2012
CODE
Lot 0201111 (use by date 5/6/2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Goodness Gardens Inc., New Hampton, NY, by press release on May 10, 2011.
Manufacturers: Goodness Gardens Inc., New Hampton, NY;
BIOHERBS C.I. E.U, BOGOTA, Colombia. Connecticut initiated recall is complete.
REASON
The product lot was found to be contaminated with Listeria monocytogenes based on sampling and analysis by the State of Connecticut.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
PRODUCT
1) Chipotle Flavor Concentrate (product code 12115649); Minor's Chipotle Flavor Concentrate (product code 11003109). Recall # F-1352-2012;
2) Ancho Lime Flavor Concentrate (product code 11003049). Recall # F-1353-2012;
3) Mushroom Peppercorn Sauce Concentrate (product code 11001719). Recall # F-1354-2012
CODE
1) Units: 1) 93885489, 00265489, and 00545489; 2) 00265489, 93385489, 93075489, and 92795489;
2) Units: 00075489 and 00555489;
3) Units: 93555489 and 00565490
RECALLING FIRM/MANUFACTURER
Nestle Professional, Cleveland OH, b y letter on March 7, 2010. FDA initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,324 Cases
DISTRIBUTION
Nationwide
PRODUCT
1) Garden Salad, 9.6 oz, Item no. 71136, UPC 20728 71136. The product is labeled in parts: "***Chef on the Run***GARDEN SALAD***Romaine Lettuce, Red Cabbage, Carrot, Buttermilk Farm Dressing, Red Bell Pepper and Cucumber***Net Weight 9.6OZ***KEEP REFRIGERATED***". Recall #F-1372-2012;
2) Deluxe Salad with Ranch Dressing 10oz, Item no. 71600, UPC 20728 71600. The product is labeled in parts: "***Mio Frattello FRESH TO GO***Deluxe Salad w Ranch Dressing***SALAD MIX WITH RANCH DRESSING, CUCUMBERS, RADISHES, RED ONIONS, BABY CARROTS, GRAPE TOMATO***Keep Refrigerated***Net Wt. 10 oz***". Recall #F-1373-2012;
3) Deluxe Salad with Caesar Dressing 10oz, Item no. 71601, UPC 20728 71601. Product is labeled in parts: "***Deluxe Salad w Caesar Dressing***SALAD MIX WITH CAESAR DRESSING CUCUMBERS, RADISHES, RED ONIONS, BABY CARROTS, GRAPE TOMATO***Keep Refrigerated***Net Wt. 10oz***". Recall #F-1374-2012;
4) Deluxe Salad with Balsamic Dressing 10oz, Item no. 71602, UPC 20728 71602. The product is labeled in parts: "***Mio Fratello FRESH TO GO***Deluxe Salad w Balsamic Vinaigrette***SALAD MIX WITH BALSAMIC VINAGRETTE DRESSING, CUCUMBERS, RADISHES, RED ONIONS, BABY CARROTS, GRAPE TOMATO***Keep Refrigerated***Net Wt. 10 oz***". Recall #F-1375-2012;
5) Delux Salad with 1000 Island Dressing 10oz, Item no. 71603, UPC 20728 71603. Product is labeled in parts: "***Mio Fratello FRESH TO GO***Deluxe Salad w 1000 Island Dressing***SALAD MIX WITH 1000 ISLAND DRESSING, CUCUMBERS, RADISHES, RED ONIONS, BABY CARROTS, GRAPE TOMATO***Keep Refrigerated***Net Wt 10oz***". Recall #F-1376-2012;
6) VA Leaf Rom 1/5# and Ice 1/5# (1/8" Shred) FMD, net wt. 10 lbs. Item no. 73065, UPC 20728 73065. The master case is labeled in parts: "***VA LEAF ROM 1/5 & ICE 1/5# (1/8"SHRED)FMD***73065***Keep Refrigerated***Net Wt. 10 lbs***". Recall #F-1377-2012;
7) VA Leaf Rom 2/5# & Ice 2/5# (1/8" Shred) FMD, net wt. 20 lbs. Item no. 73066, UPC 20728 73066. The master case is labeled in parts: "***VA LEAF ROM 2/5# & ICE 2/5# (1/8"shred) FMD***73066***Keep Refrigerated***Net Wt. 20 lbs.***". Recall #F-1378-2012;
8) VA Salad Mix "Buffalo GAP" (G&Rleaf/Car/RCAB) 4/5#, net wt. 20 lbs. Item no. 74012, UPC 20728 74012. The master case is labeled in parts: "***VA SALAD MIX "BUFFALO GAP" (G&RLEAF/CAR/RCAB) 4/5#***74012***Keep Refrigerated***Net Wt. 20 lbs***". Recall #F-1379-2012;
9) VA Cabbage Green /Red 1/4x2" Shred 5#, net wt. 5 lbs. Item no. 74197, UPC 20728 74197. The master case is labeled in parts: "***VA CABBAGE GREEN/RED 1/4"x2" SHRED 5#***74197***Keep Refrigerated***Net Wt. 5 lbs.***". Recall #F-1380-2012;
10) VA Cabbage Red " Shred 5# 5 lbs, net wt. 5 lbs. Item no. 74149, UPC 20728 74149. The master case is labeled in parts: "***VA CABBAGE RED 1/4" SHRED 5#***74149***Keep Refrigerated***Net Wt. 5 lbs***". Recall #F-1381-2012
11) VA Cabbage Green/Red w/Carrot Shred 5#, net wt. 5 lbs. Item no. 74199, UPC 20728 74199. The master case is labeled in parts: "***VA CABBAGE GREEN/RED w/CARROT SHRED 5#***74199***Keep Refrigerated***Net Wt. 5 lbs.***". Recall #F-1382-2012;
12)VA Cabbage Shred w/Colors 5 #, net wt. 5 lbs. Item no. 74129, UPC 20728 74129. The master case is labeled in parts: "***VA CABBAGE SHRED W/COLORS 5#***74129***Keep Refrigerated***Net Wt. 5 lbs***". Recall #F-1383-2012
CODE
1) Best if Used By Date May 17 to May 25;
2), 3), 4), 5) Best if Used By Date May 16 to May 26;
6), 7), 8), 9) Best if Used By Date May 15 to May 25;
10), 11), 12) Units: 051012 to 051812
RECALLING FIRM/MANUFACTURER
Pacific Coast Fruit Company, Portland, OR, by letter and telephone on May 18, 12 and press release on May 22, 2012. Firm initiated recall is ongoing.
REASON
Product recalled due to potential contamination of Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
461 cases
DISTRIBUTION
OR, WA, AK, ID
PRODUCT
1) Smiling Hara Handcrafted Unpasteurized Tempeh Traditional Soy, 12 oz., UPC: 13964447019; 2) Smiling Hara Unpasteurized Tempeh Traditional Soy, 1.5 lb. (no UPC). Recall # F-1384-2012;
2) Smiling Hara Handcrafted Unpasteurized Tempeh Black Bean SOY FREE, 12 oz. , UPC: 13964447002. Recalling Firm: F-1385-2012;
3) Smiling Hara Handcrafted Unpasteurized Black-Eyed Pea Tempeh SOY-FREE 12 oz., UPC: 13964447033. Recall # F-1386-2012
CODE
All tempeh product varieties and sizes with Best By dates between 7/11/12 and 10/25/12.
RECALLING FIRM/MANUFACTURER
Smiling Hara Tempeh LLC, Candler, NC, via Facebook on April 26, 2012 and April 30, 2012, by press releases on April 30, 2012 and May 1, 2012, and website homepage on May 1, and May 4, 2012. North Carolina initiated recall is complete.
REASON
Samples of Smiling Hara tempeh collected by the North Carolina Department of Agriculture during a routine inspection tested positive for Salmonella. Subsequent test results confirmed that the starter culture used by Smiling Hara in its tempeh products was positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approx. 5181 lbs
DISTRIBUTION
NC, GA, FL
PRODUCT
a) Private Selections Organic Baby Spinach, 5 oz plastic clamshell, UPC 0-11110-91128-5; b) Marketside Baby Spinach Organic, 10 oz plastic clamshell, UPC: 6-8113132900-2. Recall # F-1398-2012
CODE
a) Lot TFRS 130B 1503 KT34, Best By 5-25-2012; Lot TFRS 130B 1803 KT34, Best By 5-25-2012; b) Lot TFRS130B16, Best by 5-25-2012
RECALLING FIRM/MANUFACTURER
Taylor Farms Retail, Inc., Salinas, CA, by press release and letter on May 22, 2012. Firm initiated recall is ongoing.
REASON
This product tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,841 pounds
DISTRIBUTION
AK, AR, AZ, CA, CO, ID, KS, LA, MO, MT, NM, NV, OK, OR, TX, UT, WA, WY
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
PRODUCT
Solgar Brewer's Yeast 7 1/2 Grains with Vitamin B12---Dietary Supplement-- 250 Tablets---Suitable for Vegetarians---Sugar and Starch Free, UPC Code: 033984004009. Recall # F-1335-2012
CODE
Lot # 439605-01, Lot # 439605-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: NBTY, Inc., Bohemia, NY, by letters beginning April 24, 2012.
Manufacturer: Solgar Inc., Leonia, NJ. Firm initiated recall is ongoing.
REASON
The product's raw material contains Selenium.
VOLUME OF PRODUCT IN COMMERCE
15,208 bottles
DISTRIBUTION
Nationwide and Internationally
PRODUCT
German Northern Brewer Hop Pellets. The product consisted of hop pellets packaged in 11 lbs. and 44 lbs. cardboard boxes. Product was already destroyed in April 2011 so labeling is not available. Batch VA 10-362. Recall # F-1339-2012
CODE
Lot # 5604
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hop Union, LLC, Yakima, WA, by telephone and email on February 11, 2011.
Manufacturer: Hopfenveredlung St. Johann GmbH & Co. KG, Train, Germany. Firm initiated recall is complete.
REASON
The foreign supplier sprayed the product with a fungicide Fluopecolide which is not approved for use on hops in the US.
VOLUME OF PRODUCT IN COMMERCE
2,266 lbs
DISTRIBUTION
Nationwide
PRODUCT
1) Korean Pear Juice in 120 mL metal foil pouch single service container. Product of USA, UPC# 809080300084. Recall # F-1341-2012;
2) Korean Grape Juice, 110 mL metal foil pouch single service container. Product of USA. UPC #8907672547. Recall # F-1342-2012;
3) Evergreen Farm Doen Jang (Soybean Paste). Net Wt, 70 ounces (4.4 LBS) in glass jars. Product of USA. UPC# 89076725873. Recall # F-1343-2012;
4) Evergreen Farm Pear Juice Gochujang (Hot Peppeer Paste). Net Wt 70 ounce (4.4 LBS) glass jars. Product of USA. UPC # 89076726177. Recall # F-1344-2012
CODE
All products.
RECALLING FIRM/MANUFACTURER
Evergreen Orchard Farm, LLC, Hamilton, NJ, by letters on March 16, 2012. New Jersey State initiated recall is ongoing.
REASON
Juice and paste products display incorrect labeling, product descriptions and formulations.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NJ, NY, VA, MD
PRODUCT
1) Mediterranean Foccacia Net Wt 16 oz, UPC code: 200006804996. Recall # F-1355-2012;
2) Sour Dough Bread Net Wt 16 oz, UPC code: 200006702896. Recall # F-1356-2012;
3) Soft White Bread (Butter Top) Net Wt 16 oz, UPC code: 200001702891. Recall # F-1357-2012;
4) Dinner Rolls Net Wt 12 oz, UPC code: 200506602993. Recall # F-1358-2012;
5) Asiago Cheese Bread Net Wt 16 oz, UPC code: 200006604190. Recall # F-1359-2012;
6) Baguette Net Wt 8 oz, UPC code: 200006102490. Recall # F-1360-2012;
7) Ciabatta Net Wt 12 oz, UPC code: 200203903294. Recall # F-1361-2012;
8) Salt Rising Bread Net Wt 16 oz. UPC code: 200006803395. Recall # F-1362-2012;
9) Soft Garlic Bread Sticks Net WT 12 oz, UPC code: 200006504292. Recall # F-1363-2012;
10) Dark Rye Round Net WT 16 oz. UPC code: 200153602995. Recall # F-1364-2012;
11) Sweet Greek Egg Bread Net WT 16 oz, UPC code: 20021906798. Recall # F-1365-2012;
12) Raisin Bread Net Wt 16 oz, UPC code: 200006403793. Recall # F-1366-2012;
13) Glazed Raisin Bread Net WT 16 oz, UPC code: 200006203997. Recall # F-1367-2012;
14) 12" Pizza Crust Net WT 16 oz, UPC code: 200006805290. F-1368-2012;
15) Sub Buns 12 for $2.19, UPC code: 200006402192. Recall # F-1369-2012;
16) Hotdog Buns Net Wt 8oz; and Hamburger Buns 12 for $2.19, UPC code: 200006402192. Recall # F-1370-2012;
17) White Hamburger Buns 12 for $2.19. UPC code: 200006402192. Recall # F-1371-2012
CODE
1) -10) Expiration date: 5/25/12;
11) -13) Expiration date: 5/26/12;
14) - 17) Expiration date: 5/25/12
RECALLING FIRM/MANUFACTURER
Roma Bakery and Imported Foods, Inc., Lansing, MI, by visit on May 22, 2012 and May 23, 2012. FDA initiated recall is ongoing.
REASON
Product labels failed to declare wheat as an ingredient. The labels stated flour or white flour as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
52 loaves
DISTRIBUTION
MI
PRODUCT
1) Florentine Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. Recall # F-1388-2012;
2) Cheese Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. Recall # F-1389-2012
CODE
Boxes have manufacturing dated on 04-23-2012 through 5/21/2012.
RECALLING FIRM/MANUFACTURER
Best West Foods, Las Vegas, NV, by letter sent by e-mail and fax on May 22, 2012, followed up by telephone. FDA initiated recall is complete.
REASON
Soy was not included in the ingredient statement or allergen information on the label of Cheese Lasagna Rolls or Florentine Lasagna Rolls.
VOLUME OF PRODUCT IN COMMERCE
1,800 lbs
DISTRIBUTION
NV
PRODUCT
GB Select Roast Meat Type Flavor Net Wt. 55 lbs. (25 kg). Product of the Netherlands further processed in China and the US. Batch #20389-EPP Plant #55-8822. Recall # F-1399-2012
CODE
Code 1742 Date produced 07 FEB 2012 Best Before 07 FEB 2014
RECALLING FIRM/MANUFACTURER
Dsm Nutritional Products, LLC, Parsippany, NJ, by letters dated May 16, 2012 and May 18, 2012. Firm initiated recall is ongoing.
REASON
Flavor is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
13,400 kgs
DISTRIBUTION
NJ, WI, IL
PRODUCT
1) Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 oz, Refrigerated. Recall # F-1400-2012;
2) Panera, HAZELNUT CREAM CHEESE SPREAD Reduced Fat, 8 oz, Refrigerated. Recall # F-1401-2012
CODE
Expiration Dates : 5/31/12, 6/7/12, 6/14/12, 6/21/12 & 6/28/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Panera Bread LLC, Saint Louis, MO, by email on May 8, 2012.
Manufacturer: Panera, LLC, Franklin, MA. Firm initiated recall is ongoing.
REASON
Product ingredient statement reversed for Reduced Fat Honey Walnut Cream Cheese and Reduced Fat Hazelnut Cream Cheese. Product name is correct on label.
VOLUME OF PRODUCT IN COMMERCE
198,648 units of Honey Walnut and 110,718 units of Hazelnut cream cheese
DISTRIBUTION
Nationwide
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions toCDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
PRODUCT
Metoprolol Tartrate Tabets USP 50mg, Rx only, 1000-count bottle, NDC 0093-0733-10
CODE
Lot # TE1Y261, Exp 12/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellerville, PA
Manufacturer: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India
REASON FOR RECALL
Tablet Thickness: Product is being recalled due to some tablets not conforming to weight specifications.
PRODUCT
Zeosa(TM) (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable), 75 mg), Rx only, 28 day regimen, Carton (NDC 0093-2090-58) containing three (3) individual blister packs (NDC 0093-2090-28),
CODE
Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellerville, PA 18960
Manufacturer: Teva Women’s Health, Cincinnati, OH 45213
REASON FOR RECALL
Impurities/degradation products: Product is being recalled due to the potential for some lots not meeting impurity specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT
Atenolol Tablets USP, 25 mg, a) 100 count bottle (NDC 0093-0787-01), b) 1000 count bottle (NDC 0093-0787-10), Rx only. Recall # D-1362-2012
CODE
Lot #'s: a) 90A024, 90A026, Exp 09/13; b) 90A028, Exp 09/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm Initiated recall is on going.
REASON
Presence of Foreign Substance(s): This recall is being carried out due to the potential presence of stainless steel particulates in the tablets.
VOLUME OF PRODUCT IN COMMERCE
78,682 bottles
DISTRIBUTION
Nationwide
PRODUCT
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only; NSN 6505-01-274-0951, NDC 11704-600-01. Recall #D-1369-2012
CODE
Lot # 8D1082, Exp 01/13; 8D1151, Exp 03/13
RECALLING FIRM/MANUFACTURER
Meridian Medical Technologies a Pfizer, Co, Saint Louis, MO, by letters dated June 5, 2012 on June 6, 2012. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: High out of Specification levels for carbostyril, a known degradation product of diazepam.
VOLUME OF PRODUCT IN COMMERCE
83,701 autoinjectors
DISTRIBUTION
Nationwide, Italy, Singapore, Sweden, and Canada
PRODUCT
Murocel (methylcellulose) Lubricant Ophthalmic Solution (USP, 1%), 15 mL bottle, OTC, NDC 24208-280-15. Recall # D-1370-2012
CODE
Lot # 467061, 487551, 507521, 548051, 132171, 136571, 140181
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Tampa, FL, by letter and verbal notifications on July 6, 2011. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.
VOLUME OF PRODUCT IN COMMERCE
59,777 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, NDC 0781-5248-92, UPC 3 0781-5248-92 5. Recall # D-1367-2012
CODE
Lot #: BJ3186, BJ3142, Exp 12/12.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Broomfield, CO, by letter dated March 22, 2012.
Manufacturer: Sandoz Private Limited, Navi Mumbai, Maharashtra, India. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
7,545 bottles
DISTRIBUTION
Nationwide and PR
PRODUCT
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in a 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, NDC 0781-5584-36. Recall # D-1368-2012
CODE
Lot #: LF00478C, LF00479C, Exp 10/12; LF00551C, LF00552C, Exp 01/13; LF00687C, LF00688C, Exp 04/13; LF00763C, LF00764C, LF00765C, Exp 06/13; LF01261C, Exp 03/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Broomfield, CO, by press release on June 5, 2012 and by letter on June 8, 2012.
Manufacturer: Laboratorios Leon Farma SA, Leon, Spain. Firm initiated recall is ongoing.
REASON
Contraceptive Tablets Out of Sequence: Patient complaint that inactive tablets were found in row 9 of a blister card instead of the appropriate row 13.
VOLUME OF PRODUCT IN COMMERCE
31,858 unit cartons
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1121-12
CODE
Unit: 006LT46267
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter and LOGIC alert on September 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1440-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1441-12;
3) Whole Blood. Recall #B-1442-12;
4) Red Blood Cells. Recall # B-1443-12;
5) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1444-12;
6) Red Blood Cells Leukocytes Reduced Washed. Recall # B-1445-12
CODE
1) Units: 003LX34086, 003LX34287, 003LX34294, 003LX34443, 003LX34241, 003LX33832, 003LX33834, 003LX33838, 003LX33839, 003LX33863, 003LX33944, 003LX33799, 003LX33800, 003LX33803, 003LX33806, 003LX34311, 003LX34391, 003LX34212, 003LX34215, 003LX34218, 003LX34223, 003LX33949, 003LX33613, 003LX33758, 003LX33615, 003LX33623, 003LX33624, 003LX33635, 003LX33637, 003LX33641, 003LX33643, 003LX33649, 003LX33650, 003LX33655, 003LX33656, 003LX33666, 003LX33673, 003LX33674, 003LX33675, 003LX33725, 003LX34257, 003LX34258, 003LX34298, 003LX34359, 003LX34369, 003LX34374, 003LX34375, 003LX34390, 003LX34162, 003LX34219, 003LX34235, 003LX34239, 003LX33860, 003LX33866, 003LX33877, 003LX33794, 003LX34282, 003LX34327, 003LX34126, 003LX33700, 003LX33939, 003LX33783, 003LX33809, 003LX33816, 003LX33822, 003LX33824, 003LX33698, 003LX33777, 003LX34046, 003LX34053, 003LX34058, 003LX34137, 003LX34139, 003LX34168, 003LX34169, 003LX34431, 003LX34227, 003LX33723, 003LX33852, 003LX33869, 003LX33878, 003LX33718, 003LX34039, 003LX33707, 003LX33612, 003LX33678, 003LX34043, 003LX34161, 003LX33773, 003LX34068, 003LX33846, 003LX33868, 003LX33899, 003LX34360, 003LX33708, 003LX34065, 003LX34158, 003LX33883, 003LX34054, 003LX34090, 003LX34127, 003LX34146, 003LX34193, 003LX34196, 003LX34238, 003LX34349, 003LX33847, 003LX33705, 003LX33611, 003LX33625, 003LX33636, 003LX33741, 003LX33757, 003LX34037, 003LX33669, 003LX34395, 003LX33988, 003LX34000, 003LX34012, 003LX34044, 003LX34088, 003LX34121, 003LX34211, 003LX34247, 003LX34259, 003LX34269, 003LX34295, 003LX34339, 003LX33916, 003LX33947, 003LX33801, 003LX33694, 003LX33696, 003LX33711, 003LX33719, 003LX33730, 003LX33640, 003LX33659, 003LX33671, 003LX33686, 003LX33727, 003LX33732, 003LX33394, 003LX33915, 003LX34159, 003LX33898, 003LX33900, 003LX33928, 003LX33945, 003LX33946, 003LX33802, 003LX34128, 003LX34264, 003LX33831, 003LX33835, 003LX33840, 003LX33843, 003LX33805, 003LX33817, 003LX33818, 003LX33722, 003LX33642, 003LX33654, 003LX33664, 003LX33668, 003LX33670, 003LX33744, 003LX33754, 003LX34243, 003LX33685, 003LX33755, 003LX34085, 003LX34160, 003LX34132, 003LX34245, 003LX34338, 003LX33861, 003LX33862, 003LX33874, 003LX33934, 003LX34052, 003LX34170, 003LX34172, 003LX34181, 003LX33923, 003LX33785, 003LX33786, 003LX33796, 003LX33804, 003LX33826, 003LX33829, 003LX33652, 003LX33766, 003LX33771, 003LX33772, 003LX34140, 003LX34147, 003LX34092, 003LX33865, 003LX33956, 003LX34195, 003LX33995, 003LX34005, 003LX34078, 003LX34114, 003LX34122, 003LX34167, 003LX34224, 003LX34274, 003LX34335, 003LX34366, 003LX33901, 003LX33808, 003LX33721, 003LX34153, 003LX34154, 003LX34283, 003LX34284, 003LX34361, 003LX33927, 003LX33779, 003LX33952, 003LX33953, 003LX33959, 003LX33610, 003LX33679, 003LX33830, 003LX34028, 003LX33859, 003LX33709, 003LX33716, 003LX33605, 003LX33687, 003LX33749, 003LX33776, 003LX34125, 003LX34189, 003LX34221, 003LX34352, 003LX33851, 003LX33864, 003LX33875, 003LX33879, 003LX33880, 003LX33882, 003LX33887, 003LX33781, 003LX33788, 003LX33770, 003LX34061, 003LX33780, 003LX33931, 003LX33970, 003LX34035, 003LX34073, 003LX34077, 003LX34082, 003LX34116, 003LX34118, 003LX34129, 003LX34130, 003LX34133, 003LX34135, 003LX34404, 003LX34406, 003LX34410, 003LX34413, 003LX34414, 003LX34415, 003LX34417, 003LX34418, 003LX34429, 003LX34432, 003LX34435, 003LX34437, 003LX34438, 003LX34441, 003LX34444, 003LX34445, 003LX34198, 003LX34201, 003LX34202, 003LX34203, 003LX34204, 003LX34207, 003LX34209, 003LX34210, 003LX34220, 003LX34261, 003LX34263, 003LX34265, 003LX34268, 003LX34271, 003LX34272, 003LX34275, 003LX34280, 993LX34307, 003LX34316, 003LX34317, 003LX34332, 003LX33616, 003LX33621, 003LX33628, 003LX33646, 003LX33651, 003LX33662, 003LX33663, 003LX33672, 003LX33680, 003LX34026, 003LX34032, 003LX34034, 003LX34358, 003LX34336, 003LX34368, 003LX34377, 003LX34393, 003LX33906, 003LX33917, 003LX33933, 003LX33937, 003LX33941, 003LX33942, 003LX33948, 003LX33958, 003LX33960, 003LX33693, 003LX33717, 003LX33728, 003LX33735, 003LX33736, 003LX33740, 003LX33750, 003LX33752, 003LX33756, 003LX33760, 003LX33762, 003LX33763, 003LX33769, 003LX34213, 003LX34237, 003LX34244, 003LX33836, 003LX33870, 003LX33892, 003LX33897, 003LX33909, 003LX33957, 003LX33984, 003LX33789, 003LX33793, 003LX33823, 003LX33713, 003LX33629, 003LX33684, 003LX33692, 003LX33729, 003LX33745, 003LX34055, 003LX34084, 003LX34093, 003LX34094, 003LX34095, 003LX34101, 003LX34104, 003LX34108, 003LX34115, 003LX34148, 003LX34166, 003LX34173, 003LX34083, 003LX34407, 003LX34421, 003LX34424, 003LX34428, 003LX34434, 003LX34439, 003LX34442, 003LX34446, 003LX34447, 003LX34449, 003LX34232, 003LX34236, 003LX34297, 003LX34337, 003LX34340, 003LX34342, 003LX34351, 003LX33790, 003LX33614, 003LX33660, 003LX33632, 003LX33647, 003LX33648, 003LX33657, 003LX33661, 003LX33665, 003LX34047, 003LX34062, 003LX34064, 003LX34067, 003LX34070, 003LX34120, 003LX34408, 003LX34230, 003LX33973, 003LX34251, 003LX34254, 003LX34260, 003LX34279, 003LX34229, 003LX34285, 003LX34289, 003LX34290, 003LX34291, 003LX34308, 003LX34328, 003LX33884, 003LX33888, 003LX33894, 003LX33903, 003LX33967, 003LX33821, 003LX33828, 003LX34003, 003LX34007, 003LX34008, 003LX34011, 003LX34014, 003LX34016, 003LX34021, 003LX34022, 003LX34023, 003LX34042, 003LX34050, 003LX34081, 003LX34087, 003LX34097, 003LX34119, 003LX34141, 003LX34143, 003LX34149, 003LX34150, 003LX34399, 003LX34401, 003LX34402, 003LX34403, 003LX34405, 003LX34411, 003LX34448, 003LX34214, 003LX34231, 003LX34233, 003LX34242, 003LX34266, 003LX34270, 003LX34276, 003LX34277, 003LX34288, 003LX34299, 003LX34300, 003LX34302, 003LX34320, 003LX34354, 003LX34362, 003LX34372, 003LX34380, 003LX34383, 003LX34394, 003LX33837, 003LX33841, 003LX33842, 003LX33907, 003LX33951, 003LX33962, 003LX33975, 003LX33981, 003LX33982, 003LX33787, 003LX33813, 003LX33814, 003LX33825, 003LX33699, 003LX33609, 003LX33618, 003LX33743, 003LX33811, 003LX33926, 003LX33986, 003LX34069, 003LX34392, 003LX34177, 003LX34187, 003LX34205, 003LX34303, 003LX34322, 003LX34409, 003LX34074, 003LX34098, 003LX34253, 003LX34296, 003LX34318, 003LX34319, 003LX34321, 003LX34334, 003LX34341, 003LX34343, 003LX34347, 003LX33904, 003LX33921, 003LX33922, 003LX34079, 003LX34240, 003LX34389, 003LX33620, 003LX33633, 003LX33726, 003LX33738, 003LX33742, 003LX33767, 003LX33768, 003LX33919, 003LX33930, 003LX33950, 003LX33954, 003LX34038, 003LX34076, 003LX33778, 003LX34346, 003LX33701, 003LX33989, 003LX34010, 003LX34192, 003LX34125, 003LX33963, 003LX33966, 003LX34364, 003LX34056, 003LX34384, 003LX34325, 003LX33747, 003LX33791, 003LX34301, 003LX34228, 003LX34100, 003LX33914, 003LX34355, 003LX34206, 003LX33688, 003LX33795, 003LX34396, 003LX33913, 003LX33622, 003LX33925, 003LX33932, 003LX33998, 003LX34089, 003LX34124, 003LX34179, 003LX33980, 003LX33985, 003LX33848, 003LX33784, 003LX33739, 003LX33715, 003LX33714, 003LX33710, 003LX33697, 003LX33617, 003LX34348, 003LX34183, 003LX34180, 003LX34178, 003LX34157, 003LX34155, 003LX34136, 003LX33977, 003LX33976, 003LX33971, 003LX33969, 003LX33910, 003LX33902, 003LX33896, 003LX33885, 003LX33871, 003LX33867, 003LX33858, 003LX33855, 003LX33854, 003LX33850, 003LX34256, 003LX34426, 003LX34400, 003LX34105, 003LX34293, 003LX33619, 003LX33627, 003LX33630, 003LX33631, 003LX33682, 003LX33690, 003LX33691, 003LX33702, 003LX33704, 003LX33807, 003LX33810, 003LX33812, 003LX33820, 003LX33827, 003LX33993, 003LX33996, 003LX33997, 003LX34013, 003LX34134, 003LX34144, 003LX34145, 003LX34184, 003LX34188, 003LX34190, 003LX34191, 003LX34194, 003LX34331, 003LX34353, 003LX34373, 003KX34419, 003LX34422, 003LX34436, 003LX34440, 003LX33689, 003LX33964, 003LX33978;
2) Units: 003LX34324, 003LX33955, 003LX34305, 003LX33924, 003LX34080, 003LX34152, 003LX34278, 003LX34112, 003LX34165, 003LX33936, 003LX33938, 003LX34123, 003LX34329, 003LX33724, 003LX34226, 003LX34225, 003LX34386, 003LX34222, 003LX34370, 003LX33644, 003LX34006, 003LX34019, 003LX34117, 003LX34156, 003LX34174, 003LX34015, 003LX34175, 003LX33775, 003LX33759, 003LX33792, 003LX34310, 003LX34330, 003LX34365, 003LX34304, 003LX33774, 003LX33782, 003LX33815, 003LX34412, 003LX34131, 003LX34142, 003LX34164, 003LX33833, 003LX34246, 003LX34075, 003LX34036;
3) Units: 003LX33658, 003LX34045, 003LX34107;
4) Units: 003LX33638, 003LX33639, 003LX33849, 003LX33695, 003LX33645, 003LX34041, 003LX34031, 003LX34103, 003LX34030, 003LX34049, 003LX34099, 003LX34111, 003LX34197, 003LX34312, 003LX34314, 003LX34357, 003LX34378, 003LX34379, 003LX34381, 003LX34385, 003LX34102, 003LX34109, 003LX34382, 003LX33677, 003LX33876, 003LX34199, 003LX34313, 003LX34326, 003LX34096, 003LX33677, 003LX34387, 003LX34252, 003LX34208, 003LX33973, 003LX34309, 003LX34292, 003LX34255, 003LX34248, 003LX34200, 003LX34024;
5) Unit: 003LY16268;
6) Units: 003LX34216, 003LX33608
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile December 28, 2005 and December 30, 2005 and by letter dated January 4, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who may have had an incorrect hematocrit determination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
722 units
DISTRIBUTION
AL, GA, IL, MI, NY, SC, PR
PRODUCT
1) Recovered Plasma. Recall # B-1471-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1472-12
CODE
1) and 2) Unit: 0886922
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and e-mail on October 5, 2005.
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Switzerland
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1519-12
CODE
Unit: 50LH83179
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone or electronic notification on September 6, 2007 and by letter dated September 11, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1520-12;
2) Platelets Leukocytes Reduced. Recall # B-1521-12;
3) Fresh Frozen Plasma. Recall # B-1522-12
CODE
1) Units: 16GS36753, 16KS02281
2) and 3) Unit: 16GS36753
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone or electronic notification on February 28, 2007 and by letter dated March 5, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH, MA, MI, CA
PRODUCT
Source Plasma. Recall # B-1550-12
CODE
Unit: 07DTXA8519
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Denton, TX, by fax on 08/1/2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1553-12;
2) Platelets. Recall # B-1554-12;
3) Fresh Frozen Plasma. Recall # B-1555-12;
4) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1556-12
CODE
1) Units: 7863597; 4878986; 4586584; 4575102; 4867155; 4861584; 4019737;
2) Units: 4019737; 4861584;
3) Unit: 4861584;
4) Units: W091009112468; 4631096; W091009112468
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax and telephone on July 27, 2009 and August 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
OK, AL, TX
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1557-12
CODE
Unit: 1689233
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated November 1, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Fresh Frozen Plasma. Recall # B-1562-12
CODE
Unit: 42S18958
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Cleveland, OH, by telephone on July 11, 2007 and by letter dated July 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Source Plasma. Recall # B-1563-12
CODE
Units: 4040078731, 4040069241, 4040064828, 4040064030, 4040062708, 4040062091, 4040061687, 4040058078, 4040057424
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by electronic notification or facsimile on June 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IL, Switzerland, Germany
PRODUCT
Source Plasma. Recall # B-1564-12
CODE
Units: 4040065639, 4040064713, 4040064075
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by electronic notification on August 20, 2007 or by facsimile on August 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, Germany
PRODUCT
Source Plasma. Recall # B-1565-12
CODE
Units: 4090265627, 4090258506, 4090255180, 4090249337, 4090248476, 4090243206, 4090242284, 4090238267, 4090235515, 4090234137
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Columbus, OH, by electronic notification on August 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IL
PRODUCT
Source Plasma. Recall # B-1566-12
CODE
Units: 4010190528, 4010188565
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by electronic notification on February 13, 2008.
Manufacturer: ZLB Plasma, Cleveland, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
PRODUCT
Source Plasma. Recall # B-1567-12
CODE
Units: 4940042554, 4940041356, 4940040950, 4940040564, 4940039949, 4940039520, 4940039109, 4940038760, 4940037900, 4940037522, 4940037193, 4940036830, 4940036407, 4940036051, 4940035449
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by electronic notification on September 18, 2007.
Manufacturer: ZLB Plasma Inc., Hamilton, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
IL
PRODUCT
Source Plasma. Recall # B-1568-12
CODE
Units: 0530356368, 0530355633, 0530355298, 0530354852, 0530354643
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Lexington, KY, by facsimile on September 19, 2007.
Manufacturer: CSL Plasma, Lexington, KY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1569-12;
2) Plasma Frozen. Recall # B-1570-12
CODE
1) and 2) Unit: 16GQ40718
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on February 25, 2008 and by letter dated February 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, MO
PRODUCT
Source Plasma. Recall # B-1571-12
CODE
Units: 4040063941; 4040064216; 4040063174; 4040062536; 4040060319; 4040059851; 4040059189; 4040058806; 4040058132; 4040057701; 4040056990; 4040056023; 4040056720; 4040069813; 4040069097; 4040068752; 4040066134; 4040065778; 4040055508; 4040055093; 4040054555; 4040053835; 4040053411; 4040052740; 4040052293; 4040051242; 4040050635; 4040049904; 4040049687
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by e-mail February 10, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
IL, IN, Switzerland, Germany
PRODUCT
Cornea. Recall # B-1572-12
CODE
Units: 100265OSCN; 100265ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by telephone and or fax on September 6, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
IN
PRODUCT
Corneas. Recall # B-1575-12
CODE
Units: 110630OSCN; 110630ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by telephone and email on October 20, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor whose initial donor eligibility was determined with inaccurate and/or incomplete donor records, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
KY, IN
PRODUCT
Cornea. Recall # B-1577-12
CODE
Units: 100043OSCN; 100043ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by telephone and email on November 22, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1680-12
CODE
Units: GX88148, GX82353
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated April 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1583-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1584-12;
3) Cryoprecipitated AHF. Recall # B-1585-12;
4) Cryoprecipitated AHF, Pooled. Recall # B-1586-12;
5) Plasma Cryoprecipitated Reduced. Recall # B-1587-12
6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1588-12;
7) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-1589-12;
8) Fresh Frozen Plasma. Recall # B-1590-12;
9) Recovered Plasma. Recall # B-1591-12
CODE
1) Units: 1697475; 1652549; 1677134;
2) Units: 1683520; 1646887; 1608557; 1192475; 0952938; 0940117; 0920215; 0872595;
3) Unit: 1683520;
4) Units: 1646887; 1677134; 1608557;
5) Units: 1652549; 1646887;
6) Units: 1153405; 1138376; 1060176; 1005776; 1013230; 0955842;
7) Unit: 1104684;
8) Units: 1192475; 0952938; 0940117;
9) Units: 1697475; 1683520; 1677134; 1608557; 0920215; 0872595
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by telephone and letters dated October 19, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
KY, OH
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1592-12
CODE
Units: 2916514, 2838008, 1687108, 2852946, 2819826
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated March 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OH, KY
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1594-12
CODE
Unit: 50LS07292
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone and electronic notification on April 19, 2008 and by letter dated April 25, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1596-12
CODE
Unit: 50V08131
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone or electronic notification on March 18, 2008 and by letter dated March 20, 2008.
Manufacturer: American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
PRODUCT
Source Plasma. Recall # B-1597-12
CODE
Units: 07MOHH8321, 07MOHH6628, 07MOHH9552, 07MOHH4185, 07MOHH3000, 07MOHH2360, 07MOHH1130, 07MOHH0485, 07MOHG8477
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima, OH, by facsimile on February 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Austria
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
PRODUCT
Recovered Plasma. Recall # B-1122-12
CODE
Unit: 006LT46267
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter and LOGIC alert on September 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-1474-12
CODE
Units: FM52056, FM52055, FM52053, FM52052, FM46818, FM14997, FM14996
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on May 24, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
PRODUCT
Recovered Plasma. Recall # B-1518-12
CODE
Unit: 50LH83179
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone or electronic notification on September 6, 2007 and by letter dated September 11, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
PRODUCT
Recovered Plasma. Recall # B-1523-12
CODE
Unit:16KS02281
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone or electronic notification on February 28, 2007 and by letter dated March 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, MA, MI, CA
PRODUCT
Source Plasma. Recall # B-1551-12
CODE
Unit: 05DTXD5563
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by fax on October 18, 2007.
Manufacturer: BioLife Plasma Services, LP, Denton, TX. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Source Plasma. Recall # B-1552-12
CODE
Units: ST0971288; ST0971645; ST0972359; ST0972554; ST0973042; ST0973237; ST0973577; ST0973789; ST0974312; ST0977555; ST0977788; ST0978133; ST0978377; ST0978697; ST0978962; ST0979544; ST0980707; ST0982317; ST0982575; ST0982987; ST0983246; ST0983715; ST0983951; ST0984200; ST0985505; ST0986550; ST0987174; ST0987413; ST0988485; ST0988750; ST0989933; ST0990270; ST0990679; ST0991007; ST0991279; ST0991899; ST0992160; ST0992479; ST0992895; ST0995444; ST0996901; ST0997132; ST0997464; ST0997771; ST0998199
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stillwater Plasma Center LLC, Gallup, NM, by fax on December 3, 2009.
Manufacturer: Stillwater Plasma Center, LLC, Stillwater, OK. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
OK, Canada
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1558-12
CODE
Unit: 1305964
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on January 22, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1559-12
CODE
Unit: 1306110
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on January 22, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1561-12
CODE
Units: 042Y49061( 2 units), 042Y49062 (2 units), 042Y49063 (2 units), 042Y49064 (2 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Cleveland, OH, by telephone on January 31, 2007 and by letter dated February 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OH
PRODUCT
Cornea. Recall # B-1573-12
CODE
Units: 100441OSCN, 100441ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by fax dated September 19, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor whose donor eligibility could have been determined with inaccurate and/or incomplete donor records, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
Canada
PRODUCT
Cornea. Recall # B-1574-12
CODE
Units: 091159OSCN, 091159ODCN, 100008OSCN, 100008ODCN, 100113OSCN, 100113ODCN, 100314OSCN, 100314ODCN, 100327OSCN, 100327ODCN, 100350OSCN, 100350ODCN, 100433OSCN, 100433ODCN, 100545OSCN, 100545ODCN, 100981OSCN, 100981ODCN, 100987OSCN, 100987ODCN, 101015OSCN, 101015ODCN, 101083OSCN, 101083ODCN, 101105OSCN, 101105ODCN, 101147OSCN, 101147ODCN, 101153OSCN, 101153ODCN, 101173OSCN, 101173ODCN, 110098OSCN, 110199OSCN, 110199ODCN, 110209OSCN, 110209ODCN, 110216OSCN, 110216ODCN, 110243OSCN, 110243ODCN, 110370OSCN, 110370ODCN, 110371OSCN, 110371ODCN, 110384OSCN, 110384ODCN, 110412OSCN, 110412ODCN, 110444OSCN, 110444ODCN, 110447OSCN, 110447ODCN, 110543OSCN, 110543ODCN, 110671OSCN, 110671ODCN, 110677OSCN, 110677ODCN, 110737OSCN 110737ODCN, 110761OSCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN. via telephone, fax and email on September 16, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
TX, IN, NY, FL, CA, OH, FL, KY, AL, and Bangladesh, Egypt, Greece, Saudi Arabia, Venezuela
PRODUCT
Cornea. Recall # B-1576-12
CODE
Units: 100766OSCN; 100766ODCN; 110817OSCN; 110817ODCN; 110160OSCN; 110160ODCN; 110142OSCN; 110142ODCN; 110526OSCN; 110526ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by letter on November 11, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 Cornea
DISTRIBUTION
FL, OH, Saudi Arabia
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1580-12
CODE
Unit: 21LG64602
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on February 21, 2008. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of adsol additive solution added was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
PRODUCT
Source Plasma. Recall B-1582-12
CODE
Unit: CZ017371
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Columbus, OH, by fax on September 15, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
PRODUCT
Recovered Plasma. Recall # B-1593-12
CODE
Unit: 50LS07292
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone and electronic notification on April 19, 2008 and by letter dated April 25, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
PRODUCT
Recovered Plasma. Recall # B-1595-12
CODE
50V08131
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone or electronic notification on March 18, 2008 and by letter dated March 20, 2008.
Manufacturer: American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
PRODUCT
Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 5mL, 6 ml fill in a 10mL Flush Syringe, NDC 63807060055. Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis. Recall # Z-1707-2012
CODE
513602 00-001-BN 4/1/2014 513602 73-007-BB 10/1/2011 513602 74-010-BB 11/1/2011 513602 75-014-BB 1/1/2012 513602 81-008-BN 12/1/2011 513602 84-006-BN 4/1/2012 513602 84-007-BN 4/1/2012 513602 85-005-BN 5/1/2012 513602 87-010-BN 3/1/2013 513602 97-005-BN 1/1/2014 513602 99-010-BN 3/1/2014 513604 73-008-BB 10/1/2011 513604 73-009-BB 10/1/2011 513604 74-001-BB 10/1/2011 513604 74-002-BB 10/1/2011 513604 74-015-BB 12/1/2011 513604 75-001-BB 12/1/2011 513604 75-003-BB 1/1/2012 513604 75-018-BB 1/1/2012 513604 75-021-BB 1/1/2012 513604 75-022-BB 1/1/2012 513604 82-015-BN 2/1/2012 513604 84-004-BN 4/1/2012 513604 84-005-BN 4/1/2012 513604 84-008-BN 4/1/2012 513604 84-008-BN 4/1/2012 513604 84-010-BN 4/1/2012 513604 84-012-BN 4/1/2012 513604 84-018-BN 4/1/2012 513604 84-020-BN 4/1/2012 513604 85-001-BN 5/1/2013 513604 85-002-BN 5/1/2013 513604 85-004-BN 5/1/2013 513604 85-012-BN 5/1/2013 513604 90-004-BN 6/1/2013 513604 90-005-BN 6/1/2013 513604 90-011-BN 6/1/2013 513604 90-012-BN 6/1/2013 513604 91-004-BN 7/1/2013 513604 92-002-BN 8/1/2013 513604 92-003-BN 8/1/2013 513604 92-004-BN 8/1/2013 513604 92-011-BN 8/1/2013 513604 92-012-BN 8/1/2013 513604 95-005-BN 11/1/2013 513604 95-006-BN 11/1/2013 513604 95-010-BN 11/1/2013 513604 95-015-BN 11/1/2013 513604 95-016-BN 11/1/2013 513604 96-002-BN 12/1/2013 513604 96-004-BN 12/1/2013 513604 96-005-BN 12/1/2013 513604 97-008-BN 1/1/2014 513604 97-009-BN 1/1/2014 513604 97-010-BN 1/1/2014 513604 97-011-BN 1/1/2014 513604 97-015-BN 1/1/2014 513604 97-017-BN 1/1/2014 513604 97-021-BN 1/1/2014 513604 98-016-BN 2/1/2014 513604 99-002-BN 3/1/2014 60031-240 01-034-9D 5/1/2013 60031-240 03-024-9D 7/1/2013 60031-240 03-083-9D 7/1/2013 60031-240 03-112-9D 7/1/2013 60031-240 07-045-9D 11/1/2013 60031-240 08-062-9D 12/1/2013 60031-240 10-009-9D 2/1/2014 60031-240 10-026-9D 2/1/2014 60031-240 11-051-9D 3/1/2014 60031-240 87-099-9D 3/1/2012 60031-240 89-018-9D 5/1/2012 60031-240 91-037-9D 7/1/2012 60031-240 92-077-9D 8/1/2012 60031-240 92-102-9D 8/1/2012 60031-240 95-068-9D 11/1/2012 60031-240 96-007-9D 12/1/2012 60031-240 98-106-9D 2/1/2013 60031-240 99-129-9D 3/1/2013 60031-240 99-147-9D 4/1/2013 60051-1000 00-013-9D 4/1/2013 60051-1000 00-083-9D 4/1/2013 60051-1000 00-108-9D 4/1/2013 60051-1000 02-079-9D 6/1/2013 60051-1000 02-099-9D 6/1/2013 60051-1000 03-092-9D 7/1/2013 60051-1000 04-060-9D 8/1/2013 60051-1000 04-089-9D 8/1/2013 60051-1000 04-139-9D 8/1/2013 60051-1000 06-074-9D 10/1/2013 60051-1000 06-076-9D 10/1/2013 60051-1000 07-022-9D 11/1/2013 60051-1000 07-052-9D 11/1/2013 60051-1000 07-054-9D 11/1/2013 60051-1000 08-033-9D 12/1/2013 60051-1000 08-036-9D 12/1/2013 60051-1000 08-068-9D 12/1/2013 60051-1000 09-011-9D 1/1/2014 60051-1000 09-027-9D 1/1/2014 60051-1000 09-040-9D 1/1/2014 60051-1000 09-071-9D 1/1/2014 60051-1000 10-053-9D 2/1/2014 60051-1000 10-056-9D 2/1/2014 60051-1000 11-056-9D 3/1/2014 60051-1000 86-036-9D 2/1/2012 60051-1000 86-038-9D 2/1/2012 60051-1000 86-098-9D 2/1/2012 60051-1000 87-067-9D 3/1/2012 60051-1000 87-172-9D 3/1/2012 60051-1000 88-001-9D 4/1/2012 60051-1000 88-107-9D 4/1/2012 60051-1000 88-151-9D 4/1/2012 60051-1000 89-131-9D 5/1/2012 60051-1000 90-141-9D 6/1/2012 60051-1000 90-150-9D 6/1/2012 60051-1000 91-025-9D 7/1/2012 60051-1000 92-071-9D 8/1/2012 60051-1000 93-037-9D 9/1/2012 60051-1000 93-038-9D 9/1/2012 60051-1000 94-057-9D 10/1/2012 60051-1000 94-058-9D 10/1/2012 60051-1000 94-069-9D 10/1/2012 66051-240 91-015-9D 7/1/2012 66051-240 92-044-9D 8/1/2012 66051-240 92-070-9D 8/1/2012 66051-240 92-072-9D 8/1/2012 66051-240 92-073-9D 8/1/2012 66051-240 92-097-9D 8/1/2012 66051-240 92-124-9D 8/1/2012 66051-240 92-140-9D 8/1/2012 66051-240 92-142-9D 8/1/2012 66051-240 94-009-9D 10/1/2012 66051-240 94-013-9D 10/1/2012 66051-240 94-045-9D 10/1/2012 66051-240 94-140-9D 10/1/2012 66051-240 94-147-9D 10/1/2012 66051-240 95-013-9D 11/1/2012 66051-240 95-014-9D 11/1/2012 66051-240 95-109-9D 11/1/2012 66051-240 96-049-9D 12/1/2012 66051-240 96-050-9D 12/1/2012 66051-240 96-096-9D 12/1/2012 66051-240 96-097-9D 12/1/2012 66051-240 97-017-9D 1/1/2013 66051-240 97-095-9D 1/1/2013 66051-240 98-010-9D 2/1/2013 66051-240 98-018-9D 2/1/2013 66051-240 98-074-9D 2/1/2013 66051-240 99-041-9D 3/1/2013 66051-240 99-043-9D 3/1/2013 66051-240 99-079-9D 3/1/2013 66051-240 99-088-9D 3/1/2013 860051-240 00-079-9D 4/1/2013 870031-240 01-057-9D 5/1/2013 870031-240 03-032-9D 7/1/2013 870031-240 10-018-9D 2/1/2014 870031-240 88-044-9D 4/1/2012 870031-240 89-026-9D 5/1/2012 870031-240 91-078-9D 7/1/2012 870031-240 92-082-9D 8/1/2012 870031-240 98-041-9D 2/1/2013 870031-240 98-075-9D 2/1/2013 870031-240 98-139-9D 2/1/2013 870041-240 00-030-9D 4/1/2013 870041-240 03-073-9D 7/1/2013 870041-240 97-044-9D 1/1/2013 870041-240 98-033-9D 2/1/2013 870041-240 98-033-9D 2/1/2013 870051-240 02-041-9D 6/1/2013 870051-240 02-052-9D 6/1/2013 870051-240 10-017-9D 2/1/2014 870051-240 97-047-9D 1/1/2013 870051-240 98-068-9D 2/1/2013 870061-240 00-022-9D 4/1/2013 870061-240 01-054-9D 5/1/2013 870061-240 03-067-9D 7/1/2013 870061-240 08-041-9D 12/1/2013 870061-240 85-067-9D 1/1/2012 870061-240 86-062-9D 2/1/2012 870061-240 87-081-9D 3/1/2012 870061-240 88-064-9D 4/1/2012 870061-240 88-083-9D 4/1/2012 870061-240 89-027-9D 5/1/2012 E0600-55 93-007-9D 9/1/2012 E0600-55 93-039-9D 9/1/2012 E0600-55 93-089-9D 9/1/2012 E0600-55 93-090-9D 9/1/2012 E0600-55 93-094-9D 9/1/2012 E0600-55 93-131-9D 9/1/2012 E0600-55 94-059-9D 10/1/2012 E0600-55 94-093-9D 10/1/2012 E0600-55 96-029-9D 12/1/2012 E0600-55 96-037-9D 12/1/2012 E0600-55 96-046-9D 12/1/2012 E0600-55 96-082-9D 12/1/2012 E0600-55 96-093-9D 4/1/2012 E0600-55 97-024-9D 1/1/2013 E0600-55 97-029-9D 1/1/2013 E0600-55 97-097-9D 1/1/2013 513604 99-006-BN 3/1/2014 513604 99-007-BN 3/1/2014 513604 99-011-BN 3/1/2014 513604 99-018-BN 3/1/2014 30031-240 92-056-9D 8/1/2012 34031-240 01-031-9D 5/1/2013 34031-240 89-073-9D 5/1/2012 36031-240 92-057-9D 8/1/2012 36031-240 92-155-9D 8/1/2012 36031-240 95-041-9D 11/1/2012 36031-240 97-063-9D 1/1/2013 44031-240 01-043-9D 5/1/2013 44031-240 01-065-9D 5/1/2013 44031-240 90-058-9D 6/1/2012 50031-1000 03-115-9D 7/1/2013 50031-1000 87-132-9D 3/1/2012 50031-1000 97-123-9D 1/1/2013 50031-240 00-114-9D 4/1/2013 50031-240 87-179-9D 3/1/2012 50031-240 95-028-9D 11/1/2012 50051-1000 01-002-9D 5/1/2013 50051-1000 02-095-9D 6/1/2013 50051-1000 04-024-9D 8/1/2013 50051-1000 04-111-9D 8/1/2013 50051-1000 08-004-9D 12/1/2013 50051-1000 09-015-9D 1/1/2014 50051-1000 09-060-9D 1/1/2014 50051-1000 09-081-9D 1/1/2014 50051-1000 12-008-9D 4/1/2014 50051-1000 85-090-9D 2/1/2012 50051-1000 86-066-9D 2/1/2012 50051-1000 89-084-9D 5/1/2012 50051-1000 91-053-9D 7/1/2012 50051-1000 91-136-9D 7/1/2012 50051-1000 92-109-9D 8/1/2012 50051-1000 93-077-9D 9/1/2012 50051-1000 95-039-9D 11/1/2012 50051-1000 97-052-9D 1/1/2013 50051-1000 98-026-9D 2/1/2013 50051-1000 99-027-9D 3/1/2013 50051-1000 99-102-9D 3/1/2013 50051-240 01-009-9D 5/1/2013 50051-240 03-110-9D 7/1/2013 50051-240 05-068-9D 9/1/2013 50051-240 08-009-9D 12/1/2013 50051-240 09-014-9D 1/1/2014 50051-240 09-061-9D 1/1/2014 50051-240 12-014-9D 4/1/2014 50051-240 86-080-9D 2/1/2012 50051-240 87-105-9D 3/1/2012 50051-240 89-086-9D 5/1/2012 50051-240 90-049-9D 6/1/2012 50051-240 92-108-9D 8/1/2012 50051-240 93-065-9D 9/1/2012 50051-240 93-067-9D 9/1/2012 50051-240 94-020-9D 10/1/2012 50051-240 99-103-9D 3/1/2013 50051-240 99-143-9D 3/1/2013 54051-240 01-008-9D 5/1/2013 54051-240 01-050-9D 5/1/2013 54051-240 04-025-9D 8/1/2013 60051-1000 94-131-9D 10/1/2012 60051-1000 94-132-9D 10/1/2012 60051-1000 96-013-9D 12/1/2012 60051-1000 97-030-9D 1/1/2013 60051-1000 97-031-9D 1/1/2013 60051-1000 97-111-9D 1/1/2013 60051-1000 98-128-9D 2/1/2013 60051-1000 99-024-9D 3/1/2013 60051-1000 99-068-9D 3/1/2013 60051-1000 99-140-9D 3/1/2013 60051-240 00-008-9D 4/1/2013 60051-240 00-011-9D 4/1/2013 60051-240 00-101-9D 4/1/2013 60051-240 02-069-9D 6/1/2013 60051-240 04-023-9D 8/1/2013 60051-240 04-092-9D 8/1/2013 60051-240 04-130-9D 8/1/2013 60051-240 07-027-9D 11/1/2013 60051-240 07-042-9D 11/1/2013 60051-240 08-021-9D 12/1/2013 60051-240 09-039-9D 1/1/2014 60051-240 09-069-9D 1/1/2014 60051-240 10-027-9D 2/1/2014 60051-240 12-021-9D 4/1/2014 60051-240 85-120-9D 1/1/2012 60051-240 86-023-9D 2/1/2012 60051-240 86-039-9D 2/1/2012 60051-240 87-031-9D 3/1/2012 60051-240 87-050-9D 3/1/2012 60051-240 87-059-9D 3/1/2012 60051-240 88-034-9D 4/1/2012 60051-240 88-174-9D 4/1/2012 60051-240 89-137-9D 5/1/2012 60051-240 89-142-9D 5/1/2012 60051-240 90-132-9D 6/1/2012 60051-240 90-140-9D 6/1/2012 60051-240 93-017-9D 9/1/2012 60051-240 93-036-9D 9/1/2012 60051-240 94-050-9D 10/1/2012 60051-240 94-121-9D 10/1/2012 60051-240 94-125-9D 10/1/2012 60051-240 95-110-9D 11/1/2012 60051-240 96-019-9D 12/1/2012 60051-240 96-040-9D 12/1/2012 60051-240 96-045-9D 12/1/2012 60051-240 96-059-9D 12/1/2012 60051-240 97-006-9D 1/1/2013 60051-240 97-015-9D 1/1/2013 60051-240 97-016-9D 1/1/2013 60051-240 98-095-9D 2/1/2013 60051-240 98-127-9D 2/1/2013 60051-240 99-059-9D 3/1/2013 64031-240 87-101-9D 3/1/2012 64031-240 99-145-9D 3/1/2013 64051-240 01-035-9D 5/1/2013 64051-240 02-068-9D 6/1/2013 64051-240 04-027-9D 8/1/2013 64051-240 07-021-9D 11/1/2013 64051-240 09-048-9D 1/1/2014 64051-240 11-017-9D 3/1/2014 64051-240 87-060-9D 3/1/2012 870061-240 89-034-9D 5/1/2012 870061-240 90-067-9D 6/1/2012 870061-240 90-068-9D 6/1/2012 870061-240 91-137-9D 7/1/2012 870061-240 92-022-9D 8/1/2012 870061-240 92-038-9D 8/1/2012 870061-240 99-055-9D 3/1/2013 950031-1000 93-087-9D 9/1/2012 950031-240 97-124-9D 1/1/2013 950051-1000 93-066-9D 9/1/2012 960051-1000 92-141-9D 8/1/2012 960051-1000 92-160-9D 8/1/2012 960051-1000 95-095-9D 11/1/2012 960051-1000 97-094-9D 1/1/2013 E0300-35 01-012-9D 5/1/2013 E0300-35 01-030-9D 5/1/2013 E0300-35 03-081-9D 7/1/2013 E0300-35 03-111-9D 7/1/2013 E0300-35 03-114-9D 7/1/2013 E0300-35 08-043-9D 12/1/2013 E0300-35 08-069-9D 12/1/2013 E0300-35 08-070-9D 12/1/2013 E0300-35 08-072-9D 12/1/2013 E0300-35 11-047-9D 3/1/2014 E0300-35 89-072-9D 5/1/2012 E0300-35 91-103-9D 7/1/2012 E0300-35 92-055-9D 8/1/2012 E0300-35 92-058-9D 8/1/2012 E0300-35 92-154-9D 8/1/2012 E0300-35 95-040-9D 11/1/2012 E0300-35 95-140-9D 11/1/2012 E0300-35 97-062-9D 1/1/2013 E0300-35 97-112-9D 1/1/2013 E0300-35 99-008-9D 3/1/2013 E0300-35 99-146-9D 3/1/2013 E0400-35 01-042-9D 5/1/2013 E0400-35 01-064-9D 5/1/2013 E0400-35 01-066-9D 5/1/2013 E0400-35 90-057-9D 6/1/2012 E0400-35 90-192-9D 6/1/2012 E0500-55 01-003-9D 5/1/2013 E0500-55 01-017-9D 5/1/2013 E0500-55 01-049-9D 5/1/2013 E0500-55 02-094-9D 6/1/2013 E0500-55 04-013-9D 8/1/2013 E0500-55 05-076-9D 9/1/2013 E0500-55 05-079-9D 9/1/2013 E0500-55 07-024-9D 11/1/2013 E0500-55 07-063-9D 11/1/2013 E0500-55 08-001-9D 12/1/2013 E0500-55 08-042-9D 12/1/2013 E0500-55 09-016-9D 1/1/2014 E0500-55 11-012-9D 3/1/2014 E0500-55 85-092-9D 2/1/2012 E0500-55 86-079-9D 2/1/2012 E0500-55 87-131-9D 3/1/2012 E0500-55 89-085-9D 5/1/2012 E0500-55 92-107-9D 8/1/2012 E0500-55 93-064-9D 9/1/2012 E0500-55 94-035-9D 10/1/2012 E0500-55 95-053-9D 11/1/2012 E0600-55 97-105-9D 1/1/2013 E0600-55 98-004-9D 2/1/2013 E0600-55 98-069-9D 2/1/2013 E0600-55 98-081-9D 2/1/2013 E0600-55 99-032-9D 3/1/2013 E0600-55 99-034-9D 3/1/2013 E0600-55 99-118-9D 3/1/2013 E0600-55 99-135-9D 3/1/2013 PS100U 04-044-9D 8/1/2013 PS100U 04-045-9D 8/1/2013 PS100U 07-038-9D 11/1/2013 PS100U 07-039-9D 11/1/2013 PS100U 07-040-9D 11/1/2013 PS100U 09-077-9D 1/1/2014 PS100U 09-078-9D 1/1/2014 PS100U 11-014-9D 3/1/2014 54051-240 05-078-9D 9/1/2013 54051-240 07-025-9D 11/1/2013 54051-240 08-005-9D 12/1/2013 54051-240 09-063-9D 1/1/2014 54051-240 11-009-9D 3/1/2014 54051-240 85-091-9D 2/1/2012 54051-240 86-067-9D 2/1/2012 54051-240 86-082-9D 2/1/2012 54051-240 91-052-9D 7/1/2012 54051-240 91-084-9D 7/1/2012 54051-240 92-111-9D 8/1/2012 54051-240 94-033-9D 10/1/2012 54051-240 98-025-9D 2/1/2013 54051-240 99-035-9D 3/1/2013 56031-240 00-015-9D 4/1/2013 56031-240 00-115-9D 4/1/2013 56031-240 03-012-9D 7/1/2013 56031-240 03-113-9D 7/1/2013 56031-240 03-116-9D 7/1/2013 56031-240 08-067-9D 12/1/2013 56031-240 08-071-9D 12/1/2013 56031-240 08-073-9D 12/1/2013 56031-240 87-133-9D 3/1/2012 56031-240 93-088-9D 9/1/2012 56031-240 95-027-9D 11/1/2012 56031-240 95-029-9D 11/1/2012 56031-240 97-066-9D 1/1/2013 56051-240 86-088-9D 2/1/2012 56051-240 87-106-9D 3/1/2012 56051-240 89-080-9D 5/1/2012 56051-240 90-048-9D 6/1/2012 56051-240 91-058-9D 7/1/2012 56051-240 91-059-9D 7/1/2012 56051-240 91-135-9D 7/1/2012 56051-240 92-110-9D 8/1/2012 56051-240 93-062-9D 9/1/2012 56051-240 93-063-9D 9/1/2012 56051-240 94-034-9D 10/1/2012 56051-240 94-044-9D 10/1/2012 56051-240 95-030-9D 11/1/2012 56051-240 95-052-9D 11/1/2012 56051-240 97-051-9D 1/1/2013 56051-240 97-053-9D 1/1/2013 56051-240 97-071-9D 1/1/2013 56051-240 97-083-9D 1/1/2013 60031-1000 08-061-9D 12/1/2013 60031-1000 10-008-9D 2/1/2014 60031-1000 10-015-9D 2/1/2014 60031-1000 10-025-9D 2/1/2014 60031-1000 11-042-9D 3/1/2014 60031-1000 87-100-9D 3/1/2012 60031-1000 89-019-9D 5/1/2012 60031-1000 91-050-9D 7/1/2012 60031-1000 92-078-9D 8/1/2012 60031-1000 93-115-9D 9/1/2012 60031-1000 93-120-9D 9/1/2012 60031-1000 94-021-9D 10/1/2012 60031-1000 95-138-9D 11/1/2012 60031-1000 96-005-9D 12/1/2012 60031-1000 98-107-9D 2/1/2013 60031-1000 98-137-9D 2/1/2013 64051-240 88-024-9D 4/1/2012 64051-240 88-135-9D 4/1/2012 64051-240 90-127-9D 6/1/2012 64051-240 92-043-9D 8/1/2012 64051-240 92-096-9D 8/1/2012 64051-240 94-046-9D 10/1/2012 64051-240 94-049-9D 10/1/2012 64051-240 94-115-9D 10/1/2012 64051-240 96-094-9D 12/1/2012 64051-240 96-095-9D 12/1/2012 64051-240 97-110-9D 1/1/2013 64051-240 98-071-9D 2/1/2013 64051-240 99-078-9D 3/1/2013 66031-240 01-005-9D 5/1/2013 66031-240 01-062-9D 5/1/2013 66031-240 01-063-9D 5/1/2013 66031-240 03-082-9D 7/1/2013 66031-240 07-046-9D 11/1/2013 66031-240 08-060-9D 12/1/2013 66031-240 10-010-9D 2/1/2014 66031-240 91-036-9D 7/1/2012 66031-240 92-079-9D 8/1/2012 66031-240 94-010-9D 10/1/2012 66031-240 95-070-9D 11/1/2012 66031-240 96-006-9D 12/1/2012 66031-240 97-040-9D 1/1/2013 66031-240 99-130-9D 3/1/2013 66051-240 00-012-9D 4/1/2013 66051-240 01-036-9D 5/1/2013 66051-240 01-055-9D 5/1/2013 66051-240 02-065-9D 6/1/2013 66051-240 02-067-9D 6/1/2013 66051-240 02-100-9D 6/1/2013 66051-240 07-020-9D 11/1/2013 66051-240 07-031-9D 11/1/2013 66051-240 07-033-9D 11/1/2013 66051-240 07-041-9D 11/1/2013 66051-240 08-037-9D 12/1/2013 66051-240 08-048-9D 12/1/2013 66051-240 09-007-9D 1/1/2014 66051-240 09-007-9D 1/1/2014 66051-240 09-009-9D 1/1/2014 66051-240 09-022-9D 1/1/2014 66051-240 10-001-9D 2/1/2014 66051-240 10-012-9D 2/1/2014 66051-240 10-039-9D 2/1/2014 66051-240 10-049-9D 2/1/2014 66051-240 12-022-9D 4/1/2014 66051-240 12-026-9D 4/1/2014 66051-240 86-045-9D 2/1/2012 66051-240 86-047-9D 2/1/2012 66051-240 87-019-9D 3/1/2012 66051-240 88-035-9D 4/1/2012 66051-240 88-043-9D 4/1/2012 66051-240 88-152-9D 4/1/2012 66051-240 88-159-9D 4/1/2012 66051-240 89-099-9D 5/1/2012 66051-240 89-143-9D 5/1/2012 66051-240 90-034-9D 6/1/2012 66051-240 90-093-9D 6/1/2012 66051-240 90-109-9D 6/1/2012 E0500-55 96-065-9D 12/1/2012 E0500-55 97-048-9D 1/1/2013 E0500-55 98-014-9D 2/1/2013 E0500-55 98-024-9D 2/1/2013 E0500-55 99-073-9D 3/1/2013 E0500-55 99-104-9D 3/1/2013 E0500-55 99-113-9D 3/1/2013 E0500-55 99-144-9D 3/1/2013 E0600-55 00-075-9D 4/1/2013 E0600-55 00-093-9D 4/1/2013 E0600-55 00-105-9D 4/1/2013 E0600-55 01-016-9D 5/1/2013 E0600-55 01-028-9D 5/1/2013 E0600-55 02-004-9D 6/1/2013 E0600-55 02-053-9D 6/1/2013 E0600-55 02-060-9D 6/1/2013 E0600-55 03-108-9D 7/1/2013 E0600-55 04-028-9D 8/1/2013 E0600-55 04-046-9D 8/1/2013 E0600-55 04-072-9D 8/1/2013 E0600-55 04-099-9D 8/1/2013 E0600-55 04-123-9D 8/1/2013 E0600-55 06-073-9D 10/1/2013 E0600-55 06-075-9D 10/1/2013 E0600-55 07-019-9D 11/1/2013 E0600-55 07-023-9D 11/1/2013 E0600-55 07-028-9D 11/1/2013 E0600-55 07-049-9D 11/1/2013 E0600-55 07-053-9D 11/1/2013 E0600-55 08-017-9D 12/1/2013 E0600-55 08-032-9D 12/1/2013 E0600-55 08-034-9D 12/1/2013 E0600-55 08-064-9D 12/1/2013 E0600-55 09-031-9D 1/1/2014 E0600-55 09-041-9D 1/1/2014 E0600-55 09-053-9D 1/1/2014 E0600-55 10-014-9D 2/1/2014 E0600-55 10-054-9D 2/1/2014 E0600-55 10-055-9D 2/1/2014 E0600-55 86-007-9D 2/1/2012 E0600-55 86-018-9D 2/1/2012 E0600-55 86-089-9D 2/1/2012 E0600-55 86-097-9D 2/1/2012 E0600-55 88-002-9D 4/1/2012 E0600-55 88-009-9D 4/1/2012 E0600-55 88-023-9D 4/1/2012 E0600-55 88-122-9D 4/1/2012 E0600-55 88-134-9D 4/1/2012 E0600-55 88-138-9D 4/1/2012 E0600-55 89-110-9D 5/1/2012 E0600-55 90-019-9D 6/1/2012 E0600-55 90-151-9D 6/1/2012 E0600-55 90-169-9D 6/1/2012 E0600-55 90-170-9D 6/1/2012 E0600-55 90-181-9D 6/1/2012 E0600-55 91-005-9D 7/1/2012 E0600-55 91-049-9D 7/1/2012 E0600-55 92-003-9D 8/1/2012 E0600-55 92-015-9D 8/1/2012 E0600-55 92-095-9D 8/1/2012 E0600-55 92-123-9D 8/1/2012 PS100U 11-052-9D 3/1/2014 PS100U 86-024-9D 2/1/2012 PS100U 86-035-9D 2/1/2012 PS100U 90-110-9D 6/1/2012 PS100U 90-126-9D 6/1/2012 PS100U 91-139-9D 7/1/2012 PS100U 92-002-9D 8/1/2012 PS100U 93-016-9D 9/1/2012 PS100U 93-018-9D 9/1/2012 PS100U 94-119-9D 10/1/2012 PS100U 94-120-9D 10/1/2012 PS100U 95-129-9D 11/1/2012 PS100U 96-008-9D 12/1/2012 PS100U 96-012-9D 12/1/2012 PS100U 96-018-9D 12/1/2012
RECALLING FIRM/MANUFACTURER
Excelsior Medical Corp., Neptune, NJ, by letter dated May 4, 2012. Firm initiated recall is ongoing.
REASON
Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 mL syringe, 4 mL fill in 10 mL syringe, 5 mL fill in 10 mL syringe), failed Anti-Factor IIa assay for potency.
VOLUME OF PRODUCT IN COMMERCE
34,230,500 units (596 lots)
DISTRIBUTION
Nationwide, Brazil, Canada, and Colombia
PRODUCT
Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Recall # Z-1773-2012
CODE
Lot # 214117, 216117, 217117, 227117, 227118, and 228117
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letter dated March 16, 2012. Firm initiated recall is ongoing.
REASON
Certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator.
VOLUME OF PRODUCT IN COMMERCE
2,284 cases (137,040 Biological Indicators)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***" FPC - F is FuseLOX, P is Plif, C is Convex Products subject to recall: Convex - 7mm x 25mm Part Number: FPC2507 Lot Number 07110002. Convex - 8 mm x 25mm Part Number FPC2508 Lot Number 07110003. Convex - 9mm x 25mm Part Number: FPC2509 Lot Number 07110004. Convex - 10mm x 25mm Part Number: FPC2510 Lot Number 07110005. Convex - 11mm x 25mm Part Number: FPC2511 Lot Number 07110006. Convex - 12mm x 25mm Part Number: FPC2512 Lot Number 07110007. Convex - 13mm x 25mm Part Number FPC2513 Lot Number 07110008. Convex - 14mm x 25mm Part Number FPC2514 Lot Number 07110009. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Recall # Z-1783-2012;
2) Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***" FPL - F is FuseLOX, P is Plif, C is Lorditic Products subject to recall: FuseLOX Lumbar Lorditic: Lorditic - 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. Lorditic - 8mm x 25mm Part Number FPL2508 Lot Number 07110011. Lorditic - 9mm x 25mm Part Number: FPL2509 Lot Number 07110012. Lorditic - 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. Lorditic - 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. Lorditic - 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. Lorditic - 13mm x 25mm Part Number FPL2513 Lot Number 07110016. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Recall # Z-1784-2012;
3) Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Trial products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and T is Trial. Products subject to recall: FuseLOX Lumbar Trials Trial - 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. Trial - 8mm x 25mm Part Number FPT2508 Lot Number 8110002. Trial - 9mm x 25mm Part Number: FPT2509 Lot Number 8110003. Trial - 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. Trial - 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. Trial - 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. Trial - 13mm x 25mm Part Number FPT2513 Lot Number 8110007. Trial - 14mm x 25mm Part Number FPT2514 Lot Number 8110008. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Recall # Z-1785-2012;
4) Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and I is Inserter. Products subject to recall: FuseLOX Lumbar Inserter Inserter - Part Number: FPT0200 Lot Number 6110100. Quantity distributed (8) is found in table on page 5 of 6. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Recall # Z-1786-2012
CODE
1) Lot Number: 07110002 thru 07110009;
2) Lot Number: 07110010 thru 07110016;
3) Lot Number: 8110001 thru 8110008;
4) Lot Number: 6110100
RECALLING FIRM/MANUFACTURER
Captiva Spine, Inc., Jupiter, FL, by letter dated May 4, 2012. Firm initiated recall is ongoing.
REASON
FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
VOLUME OF PRODUCT IN COMMERCE
664 Units FuseLOX Lumbar Implants, 176 Trials and 20 Inserters
DISTRIBUTION
Nationwide
PRODUCT
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311. Recall # Z-1791-2012
CODE
Software version 3.2.0, 3.2.1 or 3.2.3
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 8, 2012. Firm initiated recall is ongoing.
REASON
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest score for severity and probability using the risk analysis process: - Calibration ring artifacts may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds.
VOLUME OF PRODUCT IN COMMERCE
241 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Lipofilter 3000, model ASP-CAN-2, labeled in part ***Product Usage: A fat collection canister intended for use during liposuction procedures. Recall # Z-1792-2012
CODE
Lot # 0312200152
RECALLING FIRM/MANUFACTURER
MicroAire Surgical Instruments, LLC, Charlottesville, VA, by letter dated April 26, 2012. Firm initiated recall is ongoing.
REASON
Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
VOLUME OF PRODUCT IN COMMERCE
15 devices
DISTRIBUTION
Nationwide
PRODUCT
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture Recall # Z-1793-2012
CODE
NR068K, TIBIA PLATEAU, FIXED, T0; NR070K, TIBIA PLATEAU, FIXED, T0+; NR072K, TIBIA PLATEAU, FIXED, T1; NR072K, TIBIA PLATEAU, FIXED, T1+; NR073K, TIBIA PLATEAU, FIXED, T2; NR074K, TIBIA PLATEAU, FIXED, T2+; NR075K, TIBIA PLATEAU, FIXED, T3; NR076K, TIBIA PLATEAU, FIXED, T3+; NR077K, TIBIA PLATEAU, FIXED, T4; NR078K, TIBIA PLATEAU, FIXED, T4+; NR079K, TIBIA PLATEAU, FIXED, T5
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap Implant Systems, Center Valley, PA, by telephone and letter dated February 21, 2012.
Manufacturer: Aesculap AG, Tuttlingen, Germany. Firm initiated recallis ongoing.
REASON
During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide
PRODUCT
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery. Recall # Z-1794-2012
CODE
Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
RECALLING FIRM/MANUFACTURER
Plasma Surgical Inc., Roswell, GA, by letter dated April 27, 2012. Firm initiated recall is ongoing.
REASON
Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide and UK
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
PRODUCT
1) SHOWMAXX Zilmax (zipaterol hydrochloride 4.8%). Formulated by: Bob Beville, Consulting Nutritionist Nutrition Service Associates Net Weight: 10 lbs. Total Weight: 11 lbs. Recall # V-075-2012
2) SHOWFLEXX MEDICATED with Optaflexx by ELANCO ANIMAL HEALTH, A Feed Supplement for Market Cattle during the final stage of the finishing period. Formulated by: Bob Beville, Consulting Nutritionist with Nutrition Service Associates Net Weight 15 lb (6.8 Kg.) MEDICATED ACTIVE INGREDIENT Ractopamine hydrochloride 800g/ton. Recall # V-076-2012
CODE
1) All lots manufactured and distributed between December 15, 2010 and November 15, 2011 including but not limited to lots: 02031103, 09241101, 10251101, 06141101, 01201101, 01141102, 07211101, 06141101, and 01211102;
2) All lots manufactured and distributed between December 09, 2010 and February 7, 2012 including but not limited to lots: 11201205, 12060204, 12070210, 12070211, 11201201, and 11201202
RECALLING FIRM/MANUFACTURER
Recalling Firm: XF Enterprises, Inc., Hereford, TX, by telephone on March 15, 2012 and by letter on April 2, 2012.
Manufacturers: Xtra Factors Inc., Ephrata, PA;
Dutchman Feed Mills Inc., Stevens, PA. Firm initiated recall is ongoing.
REASON
The products are missing required labeling and manufactured at an unlicensed feed mill.
VOLUME OF PRODUCT IN COMMERCE
7,373 buckets
DISTRIBUTION
TX and IA
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
PRODUCT
Excede, Ceftiofur Crystalline Fee Acid Sterile Suspension, 100 ml Equivalent to 200 mg/mL ceftiofur, NADA #141-209, Pfizer. Recall # V-077-2012
CODE
Units: 0BMHX, 0BTP7, 0BTP6, 0BTPB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on May 24, 2012.
Manufacturers: Pharmacia & Upjohn Company LLC, Kalamazoo, MI;
Pfizer Inc., New York, NY. Firm initiated recall is ongoing.
REASON
Stability testing yielded an Out of Specification (OOS) result below the limit for rate of release.
VOLUME OF PRODUCT IN COMMERCE
16,844 bottles
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JUNE 13, 2012