Dan Nelson Dairy Pre-mix R Dairy mineral pre-mix with Monensin at 509g/ton  Product  #WIK361  Lot #21413J
Custom blend of mineral pre-mix was found with high levels of monensin up from 800 g/ton to 26,000 g/ton
Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
MERRSM - MERRELL MEDICATED STOCK MIX -- For Further Manufacture of Feed -- MEDICATED -- ACTIVE DRUG INGREDIENT: Monensin (as Monensin Sodium) 6000 g/ton.  Ingredients: Processed Grain By-Products and Calcium Carbonate --- Manufactured For: Eagle Supply Company, LLC, PO Box 4844, Syracuse, NY 13221 --- Rumensin 90 - NADA # 95-735, Production Date 12/18/13
Lot Number 39155 (The full lot code of the tag will read 1335239155)
Firm received an adverse reaction report from a farm.  Private lab analysis of stock mix revealed sodium monensin at 470% of label claim (super-potent).
FCI RUMENSIN 10 G Premix (FCIRUM10), MEDICATED --- ACTIVE DRUG INGREDIENT: Monensin, USP . . . . . 20,000 g/ton;  Guaranteed Analysis: Calcium, (Min) . . . 31 % , (Max) . . . 35% LIST OF INGREDIENTS: Calcium Carbonate and Mineral Oil --- Rumensin 90 - NADA # 95-735  --- Manufactured for: Feed Commodities Int., Inc., Middlebury, VT. 05753  -- Net Wt. 50 lbs (22.68 kg) FCIRUM10
Lot Number 39156 (The full lot code of the tag will read 1335239156)
Private lab analysis of stock mix revealed monensin at 34% of label claim (sub-potent).
Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
Circular Lock Screws, part # G826, lot # 11406.  The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).
The devices being recalled have a catalog number of G826 and a lot number of 11406.
The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.
Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada
EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
Part number 9079-VC-005; lot code 3606455
The voluntary recall is due to the needle set not meeting its specifications.
Genzyme Thymoglobulin [Anti-thymocyte Globulin (Rabbit)], 25 mg  (NDC 58468-0080-01)
Anti-Thymocyte Globulin (Rabbit) 25 mg, with a trend approaching the upper limit on the molecular size distribution tests for polymers, aggregates and fragments, was distributed.
SOURCE PLASMA CAUTION: FOR MANUFACTURING USE ONLY PLASMA SEPARATED FROM WHOLE BLOOD CONTAINING APPROXIMATELY 50-120 mL OF ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USING AN AUTOMATED PROCEDURE 1. Store at -20C or colder. 2. Plasma collected from a normal donor.  BioLife Plasma Services L.P. One Baxter Parkway
Source Plasma, collected from ineligible donors, were distributed.
Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189
Best Before Dates of July 15, July 29, Aug 12, and Aug 26, 2014
Printing error by the packaging manufacturer erroneously added a ''GF'' symbol to the packages.
Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.
eye-pak 7407 Tray Support Cover REF 8065740745
The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.
UltraStream Peel Away Kit   The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Worldwide Distribution -  US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.
Minstrel (with scale)   Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to  safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.
ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. As a result, the spreader bar can eventually fully unscrew and become detached from the scale and the lift arm, and drop to the floor. Consequently, the person suspended in the sling that is hooked up to the spreader bar could also drop, and/or the spreader bar could drop onto the person, causing serious injury.
AXIOM Artis or Artis zee system   Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
Blood product, collected from a donor who had been incarcerated, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Dehydrated minced green onion sold under the Silva brand and packaged in 28 lb. box.
Silva International Inc. is a lot of recalling Minced Green Onion, ''Irradiated'' due to reported Salmonella contamination.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
ViroSeq HIV-1 Genotyping System v2.0, consisting of ViroSeq HIV-1 Genotyping System v2.0 reagent kit and Genotyping Software v3.0.  Also contains ViroSeq HIV-1 Genotyping Software Manual and System v2.0 (3130) Operators Manual
ViroSeq HIV-1 Genotyping System v2.0 (reagent kit), Abbott Product List Number 4J9491, Celera Part Number 5002979;   ViroSeq HIV-1 Genotyping Software v3.0 and Algorithm Advisor, Abbott Product List Number 4J9427, Celera Part Number 5003671- Software Revision v3.0, Build v3.0.0.32;     ViroSeq HIV-1 Genotyping Software v3.0 Software Manual, Abbott Product List Number 4J9428, Celera Part Number 5003698;    ViroSeq HIV-1 Genotyping System v2.0 (3130) Operator's Manual, Abbott Product List Number 4J9457, Celera Part Number 5002960.
ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed.
Product was sold in retail stores in Texas and Louisiana and directly to consumers in Texas, New York, Louisiana, Florida, and Virginia via Internet sales.
Oriya organics  Superfood Protein Medley   Sprouted Chia Seeds Spirulina  Sprouted Brown Rice Protein   Hemp Protein Chlorella  in NET WT. 21.2 OZ. (600 g) white poly bottles  USDA ORGANIC
Product may be contaminated with Salmonella.
Artis zee and Artis zeego systems.    x-ray, angiographic system
running software version VC21B    10094135, 10094137, 10094141, 10280959 with multiple serial numbers .
There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
*** US: Nationwide (CA, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, TX, VA, WA); *** FOREIGN: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CAMBODIA, CHINA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, LEBANON, LIBYA, MALAYSIA, MAURITIUS, MOLDOVA, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NORTH KOREA, PAKISTAN, PERU, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, VENEZUELA, VIETNAM, YEMEN
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures.    Type of packaging:   - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch.   - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).
1) Item reference: 73P20B , Batch number: 1902 , Expiration date: 09/2018 , GTIN on box label: 3661522016527 ; 2) Item reference: 73P20B , Batch number: 987180 , Expiration date: 07/2018 , GTIN on box label: 3661522016527 ; 3) Item reference: 73P20B , Batch number: 997390 , Expiration date: 08/2018 , GTIN on box label: 3661522016527 ; 4) Item reference: 73P30AA , Batch number: 932870 , Expiration date: 02/2018 , GTIN on box label: 3661522016701 ; 5) Item reference: 73P30AG , Batch number: 931880 , Expiration date: 12/2017 , GTIN on box label: 3661522029510 ; 6) Item reference: 73P30AG , Batch number: 932880 , Expiration date: 01/2018 , GTIN on box label: 3661522029510 ; 7) Item reference: 73P30AG , Batch number: 952490 , Expiration date: 03/2018 , GTIN on box label: 3661522029510 ; 8) Item reference: 73P30AG , Batch number: 954720 , Expiration date: 04/2018 , GTIN on box label: 3661522029510 ; 9) Item reference: 73P30AG , Batch number: 961280 , Expiration date: 06/2018 , GTIN on box label: 3661522029510 ; 10) Item reference: 73P30AG , Batch number: 967610 , Expiration date: 07/2018 , GTIN on box label: 3661522029510 ; 11) Item reference: 73P30AG , Batch number: 967620 , Expiration date: 10/2018 , GTIN on box label: 3661522029510 ; 12) Item reference: 73P30AG , Batch number: E04258 , Expiration date: 12/2018 , GTIN on box label: 3661522029510 ; 13) Item reference: 73P30AI , Batch number: 2415 , Expiration date: 10/2018 , GTIN on box label: 3661522016923 ; 14) Item reference: 73P30AI , Batch number: 911280 , Expiration date: 11/2017 , GTIN on box label: 3661522016923 ; 15) Item reference: 73P30AI , Batch number: 953070 , Expiration date: 03/2018 , GTIN on box label: 3661522016923 ; 16) Item reference: 73P30AI , Batch number: 997980 , Expiration date: 09/2018 , GTIN on box label: 3661522016923 ; 17) Item reference: 73P30AM , Batch number: 5006 , Expiration date: 01/2019 , GTIN on box label: 3661522024348 ; 18) Item reference: 73P30AM , Batch number: 913570 , Expiration date: 12/2017 , GTIN on box label: 366152202
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
Worldwide Distribution- US: Nationwide (CA, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, TX, VA, WA); and countries: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CAMBODIA, CHINA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, LEBANON, LIBYA, MALAYSIA, MAURITIUS, MOLDOVA, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NORTH KOREA, PAKISTAN, PERU, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, VENEZUELA, VIETNAM, YEMEN
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters.     Type of packaging:     - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch.   - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).
Blood products, collected from a donor for whom there was no record of an arm inspection, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, labeled with incorrect expiration dates, were distributed.
Product was distributed nationwide; foreign (globally); and Government/VA consignees.
Terumo BCT Lake wood, CO 80215, Catalog No 61000 Spectra Optima Apheresis System, Country of Origin: US.
Catalog number 61000 (all serial numbers)
Spectra Optia Apheresis Systems Return Line Air Detector (RLAD) Sensors, associated with component failure which may disrupt or end an ongoing apheresis procedure, were distributed.
CA, CO, CT, FL, GA, IA, IN, MO, NH, NY, PA, TX, and WA
Lakewood Organic Fresh Pressed GMO Free Pure Apple Cold Pressed Not from Concentrate Juice Fruit 32 FL OZ (1 QT) 946 mL  Lakewood Miami, FL 33127
Found to have levels of inorganic arsenic that exceeds FDA levels of concern limits.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, labeled with an incorrect expiration date, was distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, which was labeled with an incorrect expiration date, was distributed.
Blood product, with a low platelet count, was distributed.
Pedi-Pak Quad 75mL with In-Line Filter Transfer Pak Rx Only  75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601  TEL:201-708-1408  FAX: 201-708-1104    Genesis BOS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16
Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed.
Pedi-Pak Quad 75mL Transfer Pack w/o filter Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601  TEL:201-708-1408  FAX: 201-708-1104    Genesis BOS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16
Pedi-Pak Quad 75 mL Transfer Pack - Needless 'Y'' site Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601  TEL:201-708-1408  FAX: 201-708-1104    Genesis BOS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16
Pedi-Pak Single 75 mL Transfer Bag -Single Rx Only 75 mL Genesis BPS, LLC 65 Commerce Way, Hackensack, NJ 07601 Tel: 201-708-1400 Fax: 201-708-1104    Genesis BPS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16
Penrose-St Francis Health Services Blood Bank
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
The product is labeled in part ''***Arise & Shine Hydrated Bentonite Dietary Supplement Extra Thick Formula 32 FL OZ ***% Daily Value Iron 0***Distributed by: Arise & Shine Herbal Products 562 Parsons Drive Medford, Oregon 97501***'' Product is packaged in a foil pouch with a plastic screw-on lid.  UPC 701088032067
Arise & Shine Herbal Products, Inc. is voluntarily recalling Hydrated Bentonite 32 oz liquid pouch due to mis-labeling. The product is labeled as containing 0% Daily Value of iron and  actually contains 106% Daily Value of iron.
Tunas Turkish Delight Rose Flavored, Net Wt. 14.11 oz., US Importer and Distributor: Turkana Food, Inc., Exporter: Tunas Food Industry, UPC 86925940080
Tunas Turkish Delight Rose Flavored contains Ponceau 4R which is an unapproved color in the US.
Boku Super Protein 3.0, Product Sizes: 21.2 oz, 1 oz., bulk.
Boku is recalling Super Protein because it may be contaminated with Salmonella.
Boku Super Food 2.0, Product Sizes: 28.2 oz
Boku is recalling Super Food because it may be contaminated with Salmonella.
Boku Super Food 3.0, Product Sizes: 10 oz.
Product was distributed to a DC in Greenville SC.  It was further distributed to retail stores under the authority of Topco. owner of the product.
Product is packaged in a cardboard box and labeled in part, ''SOUTHERN HOME Mozzarella Sticks***CONTAINS: WHEY, MILK, EGG, SOY***DISTRIBUTED BY SOUTHERN HOME P.O.BOX 99 MAULDIN, SC 29662***''   6/case 30oz  UPC 607880027150
Incorrect declaration of allergens.  The ingredient label properly lists the wheat allergen but the ''Contains'' statement does not.
Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland.
CareFusion AirLife Heated Infant Breathing Circuit   Product Usage:  Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2) CIRCUIT RESP INFANT 4FT 30/CS , Product Code 10331N-4S2 ; 3) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10351-4H2 ; 4) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10387-4S2 ; 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 10392-503 ; 6) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10485-4H2 ; 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS , Product Code 10520-504 ; 8) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10555-4S2 ; 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code 10680-504 ; 10) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10706-4S2 ; 11) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10790-4S2 ; 12) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10814-4S2 ; 13) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10849-4S2 ; 14) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 10865-4H2 ; 15) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10868-4S2 ; 16) CIRCUIT RESP DISP INF HTD 30/CS , Product Code 1175-4H2 ; 17) CIRCUIT RESP INFANT DUAL DISP 30/CS , Product Code 1208-4H1 ; 18) CIRCUIT RESP INFANT DISP 30/CS , Product Code 1553-4H1 ; 19) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 1815-409 ; 20) CIRCUIT RESP INFANT 3FT HTD HI FI 30/CS , Product Code 1998-4H1 ; 21) INFANT RESP CIRC HTD 4 FT. , Product Code 2119-4S2G ; 22) INFANT RESP CIRC HTD 4 FT. , Product Code 2120-4S2G ; 23) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 4319-4H2 ; 24) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4326-4H2 ; 25) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4652-501 ; 26) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4677-4H2 ; 27) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4875-4H2 ; 28) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5665-4H2 ; 29) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 5682-409 ; 30) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5732-4H1 ; 31) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5868-4H2 ; 32) CIRCUIT RESP I
The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it.  Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).
VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).
The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553  used in Centurion Convenience Kits.  Recalled product is attached to the outside of the Convenience Kits.
0.9% Sodium Chloride Injection, USP  BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits:  Kit Code/Description:  CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers:  2013082850, 2013092650; Kit Code/Description:  CVI3240/PORT ACCESS KIT, Lot Number:  2013111180;    Kit Code/Description:  CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers:   2013081350,2013082950, 2013091250;   Kit Code/Description:  CVI3525/UNIVERSAL BUNDLE PACK, Lot Number:  2013052880;  Kit Code/Description:  CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers:  2013092450, 2013081950;  Kit Code/Description:   DT10560/INFUSION PORT ACCESS KIT, Lot Number:  2013061780;   Kit Code/Description:  DT10620/FISTULA KIT, Lot Number:  2013082150;  Kit Code/Description:  DT11270/VAD KIT, Lot Number: 2013051380;   Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980;  Kit Code/Description:  DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers:  2013052880,   2013111180;   Kit Code/Description:  DT12955/UNIVERSAL PROCEDURE PACK, Lot Number:  2013091750;   Kit Code/Description:  DT13610/PICC INSERTION KIT, Lot Numbers:  2013061780, 2013062480;  Kit Code/Description:  DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number:  2013052080;   Kit Code/Description:   DT14645/PORT ACCESS TRAY, Lot Number: 2013120280;   Kit Code/Description:  DT14680/CAP CHANGING KIT, Lot Numbers:  2013061080, 2013061780;  Kit Code/Description:   DT14835/CAP CHANGE KIT, Lot Number: 2013111180;  Kit Code/Description:  DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number:  2013102880;  Kit Code/Description:  DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers:  2013050680, 2013040180, 2013061080;   Kit Code/Description:  DT15220/STERILE CAP CHANGE, Lot Numbers:  2013052880, 2013061080;  Kit Code/Description:  DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180;   Kit Code/Description:  DT17300/NEONATAL CAP CHANGE
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated Washed
Blood products, possibly contaminated with air, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
American Red Cross Blood Svs. Indiana-Ohio Region
Blood product, possibly contaminated with air, was distributed.
Blood products, shipped using coolers that had not been validated and possibly reached unacceptable temperatures, were distributed.
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Nationwide and worldwide.  No VA/govt/military.
TerumoBCT, Lakewood, CO 80215 USA.  Catalog No: 6100 Spectra Optia Apheresis System
Catalog Number: 61000; Serial Number 1P00000
Spectra Optia Apheresis Systems with version 11 software, associated with unexpected behavior regarding rinseback,  were distributed.
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
Lot: 12RIF4A, Expiration Date: 9/30/2014
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI.
CareFusion EnVe and ReVel Ventilators.   The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator.  The input port on the ventilators must have the adapters correctly aligned to function properly.  Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and preventing charge to the ventilator battery.
Worldwide Distribution - USA including  AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain.
Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14
Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, group and Listeria spp.  In addition, BC-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis.   BC-UP is indicated for use in conjunction with other clinical and laboratory findings to, aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to, monitor these infections. Sub-culturing of positive blood cultures is necessary to recover, organisms for susceptibility testing, identification of organisms not detected by BC-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings.    Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.     Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging.     If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ fac
Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria:  - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari),   - Salmonella species,   - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri),   - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus),   - Yersinia enterocolitica.     In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2.   EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.   Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens.   Concomitant culture is necessary for organism recovery and further typing of bacterial agents.   EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may no
Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14
Worldwide Distribution- US Distribution including the states of : AZ, CA, GA, KY, MI, MN, MO, MS, NC, NE, NY, OH, PA, SC, TX, VA, and WA., and Internationally to Canada and Hong Kong.
No packaging.  Device is a wheel chair. Fuze T50, Fuze T20 and Fuze T50 Jr
The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.
BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 3065553.   Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306533).
Roots, Original Hummus, Net Wt. 8oz (227 g), and 16oz (454 g), Gluten-Free Vegan, UPC: 860971000009, and 723175787629, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14''
4063 cases (6x8oz & 16oz units per case)
Although ingredient statement lists ''Tamari,'' Label lacks statement, ''Contains Soy.''
Roots, Roasted Garlic Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000016, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''
Roots, Thai Coconut Curry Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000092, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
Roots, Roasted Red Bell Pepper Hummus, Net Wt. 8oz (227 g), and 16oz. (454 g), Gluten-Free Vegan, UPC: 860971000023, and 723175787605, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
Roots, Hot Chipotle Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000054, and 723175787612, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
Roots, Black Bean Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000030, and 723175787636, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
Products are labeled with a 'Best By' date of 08/25/14 or prior.  ie.  ''BEST BY: 08/25/14''
Roots, Spinach Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 860971000047, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
Roots, Lima Bean Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs.
Roots, Oil Free Original Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs.
Condensed Skim Milk in bulk tanker (approximately 40,000 pounds per tanker load)
Two loads of raw milk shipped from Beaver Creek Farm located in Coopersville, MI tested positive for Supra Sulfa III (Sulfamethazine). One load was co-mingled with other loads of raw milk at the DFA facility in Adrian, MI and processed into cream and condensed skim milk. The second load went directly from the producers farm to Continental Dairy Facilities, LLC in Coopersville, Michigan and was further processed.
Cream (Bulk; approximately 40,000 pounds per tanker load)
Raw Milk (Bulk; approximately 40,000 pounds per tanker load)
Garden Fresh Egg Salad, Code #2022, Net Wt. 5 lbs. (2.268 Kg)  UPC 11596-52022
Garden Fresh Foods, Inc. is recalling Garden Fresh Egg Salad because it has the potential to be contaminated with Listeria monocytogenes.
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
STAT 2 Flow Controller; 80'' (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801.    Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU is recalling the ConMed Stat 2 flow controller because it may  deliver a significantly higher flow rate than was intended.
STAT 2 Flow Controller; 80'' (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802.    Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
83'' (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897.   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
98'' (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648.   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to  Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
No packaging.  The device is a computed tomography scanner.     Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Model 728243 Software version 2.2.1 and 2.2.2
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646   Product Usage:  ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated.  Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.
Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments.  Use of a nonconforming sample probe cable can casuse a delay in reporting results, but will not cause erroneous results.
STAT 2 Flow Controller; 26'' (66 cm) Appx 2.8 mL, 15 Drop Admin Set w/2 Clave, STAT 2 Flow Controller, Inj Site, MicroClave, Item No. AH7007.
ICU is recalling the ConMed Stat2 flow controller because it may deliver a significantly higher flow rate than marked on the controller.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system    Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).
Disposable Patient Circuit that allows water to leak into the center gas lumen
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system    Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system    Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High.  For use with the Precision Flow system and Ikaria INOmax DSIR   System.  This DPC allows clinicians to administer nitric oxide non-invasively via high  flow nasal cannula. In the Precision Flow High Flow Therapy application, a  special disposable patient circuit re-routes the gas to the INOmax injector  module then back into the Precision Flow system  Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low.  For use with the Precision Flow system  Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low.  PF-DPC-Low packaged with compatible cannulas for evaluation of the  Precision Flow system
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low.    For use with the Heliox Precision Flow system  Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low.    For use with the Precision Flow system and Ikaria INOmax DSIR   System.  This DPC allows clinicians to administer nitric oxide non-invasively via high  flow nasal cannula. In the Precision Flow High Flow Therapy application, a  special disposable patient circuit re-routes the gas to the INOmax injector  module then back into the Precision Flow system
Water may leak into the center gas lumen of the  Patient Circuit
Distributed wholesale to retailers only within Puerto Rico.
La Orocovena, Pound Cake Queso, NET WT. 2 OZ. (56.7 grams)
08112014  to 101214 (numbers correspond to manufacturing and distribution date)
Undeclared allergens: milk, wheat, soy, yellow 5&6 and red 40.
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Worldwide Distribution- US (nationwide) including states: MA, MN, NY and Puerto Rico; and countries: Canada, Mexico, Dubai, Australia, Chile, Columbia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Model #'s 66800059, all lots since product launched 01/16/2009
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Distributed in the states of Colorado, California and New York.
Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6.   The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.
JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.
Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only   It is a replacement cartridge used when more than one firing is required during a surgery.
4C GRATED CHEESE HOMESTYLE 100% NATURAL PARMESAN, NET WT. 6 OZ. (170g) glass jars, UPC Number:0-41387-32790-8.  Manufactured by 4C FOOD CORP., BROOKLYN, NY 11208.  Product of USA.
3,696 total units (308 cartons x 12 jars per carton)
4C Foods Corp. has recalled 4C HomeStyle Parmesan Grated Cheese due to Salmonella contamination.
The Ysio Systems with software version VC10   The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image.  If these artifacts appear in the region of interest, the examination may need to be repeated.
Supreme brand Colossal Crab Meat, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company,   Villa Park, IL 60181
Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage.
Supreme brand Special Crab Meat, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Sebastian Supreme brand Super Lump  Crab Meat, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Supreme Choice brand Claw , 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Supreme Choice brand Special, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Supreme Choice brand Backfin, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Supreme Choice brand Super Lump, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Supreme Choice brand Jumbo Lump, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Supreme Choice brand Colossal, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Blue Star Claw Crab Meat, 16 oz; Premium Pasteurized Crab Meat.  Product of Thailand.  Distributed by Supreme  Lobster and Seafood Company, Villa Park, IL 60181
Fresenius Naturalyte Liquid Bicarbonate Concentrate  Product Number: 08-4000-LB    The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Product was held at temperature above the labeled recommended storage temperature
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only.  Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY  13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10  Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Phoenix Produce is recalling Chinese Style Noodles because it contains undeclared FD&C Yellow No. 5, Yellow No. 6, and Red No. 40.
Tradiciones' Andinas Purple Corn Drink Chicha Morada, Net Wt: 33,81 Fl. oz. (1 Lt.), Distributed by: JP Trading and Global Imports LLc, Newark, NJ 07102 (973) 242-3143, Toll free (888) 606 PERU, NDC 854219002795
a) ML:N.CH Lot 08-14 with expiry date 04/05/2015 and b) ML:N.CH lot 09-14 with expiry date 05/05/2015
Tradiciones' Andinas Purple Corn Drink Chicha Morada  contains undeclared FD & C Blue #1, Yellow #5 and contains unallowable dye: 16185- Amaranth (E123) - delisted FD & C Red 2.
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Worldwide Distribution-US Distribution including the states of IL, SC, VA, TX, MA, NC, LA, CA, AL, CO, NE, OR and KS., and Internationally to Canada.
DePuy Synthes TI Vectra Plates:   TI Vectra-One'' Plate 2 Level / 34 mm   part 04.613.184   3337672    TI Vectra'' Plate 3 Level / 57 mm   part 04.613.257   lot 3693878    TI Vectra'' Plate 4 Level / 64 mm   part 04.613.364   lot 8143905
TI Vectra-One'' Plate 2 Level / 34 mm  part 04.613.184   3337672    TI Vectra'' Plate 3 Level / 57 mm   part 04.613.257   lot 3693878    TI Vectra'' Plate 4 Level / 64 mm   part 04.613.364   lot 8143905
DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems.  The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the inability to lock the screw onto the plates.
Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, and Puerto Rico and to the following countries: Argentine, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, Guam, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.   Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.     Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
82 units distributed in US and 140 units distributed outside US
The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally.   The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
Product was shipped to the following States: WA, CA, NY, WI, TX, CO, PA, IN, MD and IL.
Natural Blue Diamond Almonds Artisan Nut-Thins crafted with brown rice, almonds & Chia Seeds Wheat & Gluten free  Net wt. 4.25 oz. Box. (120.5g)  Cracker Snacks  UPC: 41570 10938  Best Before Dates: AUG 06 15 and AUG 07 15    Manufactured for:  Blue Diamond Growers  1802 C St.  Sacramento, CA 95811
UPC: 41570 10938  Best Before Dates: AUG 06 15 and AUG 07 15
Gluten Protein detected up to 50 ppm in product with gluten free statement.
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)  and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL  35811
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Recombinant Vaccine
GARDASIL, one lot with the potential for small glass particles to be present in the vial, was distributed.
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.  NDC 68968-5554-3.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.