Recalling Firm
ErgoSafe Products, LLC (DBA) Prism Medical
Blood Centers of the Pacific - Irwin Center
Poudre Valley Health Care, Inc. Blood Bank
Philips Electronics North America Corporation
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Consumer Product Distributors Inc. dba J Polep Distributif
Sight Society Of Northeastern New York Lions Eye Bank@Albany

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.
Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.
Worldwide Distribution - US Nationwide and the countries of:Canada, Great Britain, Australia, South Korea, and Japan.
US: AL, AR, AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY. OUS: Libya, Colombia.
Nationwide throughout the US and Chile, Trinidad, China
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OR, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Alaska, Hawaii and the District of Columbia, and the countries of Argentina, Australia, Austria, Canada, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, Iceland, Israel, Italy, Japan, Netherlands, Norway, Oman, Poland, Portugal, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, United Arab Emirates, and United Kingdom.
U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA
Distributed in the states of AZ, CO, MI, MN, NC, OH and TX.
Nationwide Distribution including Puerto Rico and to the states of : CA, CO., CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OA, PA, SC, SD, TN, TX, VT, VA, WV and WY.
Worldwide Distribution - US Nationwide including Canada.
NY, NJ, PA, VA, MA, MD, GA via H Mart retail stores
Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.
Domestic: AL, AZ, CA, CT, FL, GA, ID, IL, KS, KY, MA, MI, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, WA, WI Foreign: None VA/DOD: None
U.S. Nationwide Distribution and the country of: Canada
US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
Distributed in DC and the states of CO, CA, FL, TX, and AR.
US Nationwide Distribution in the states of: PA, IN, IA and SC.
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Dem. Rep. Congo, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela and Vietnam.
Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.
Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.

Product Description
Blood and Blood Products for Reprocessing
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
Nut Free Pesto, packaged in a institutional size 28 lbs. and 30 lbs. container, sold under brand Rising Sun Farms, UPC 0 18646 48075 9
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.
ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.
ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a ''V'' shape between clamp and drape.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member.
Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight specification of 600 lbs (273 kg). Product Usage: The P-600 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member.
Platelets Pheresis Leukocytes Reduced Irradiated
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, a Mixing System, Targeting K-Wires and a Delivery Needle (Cannula). Model number 10801210. InjectionPlasty 1.0 is indicated to fill bony voids or gaps of the skeletal system
Fat Free Pasteurized Prepared Cheese Product: SOUTHHOME 12/12OZ AMERICAN FAT FREE YELLOW, 0788001319. ROUNDYS 12/12OZ AMER FAT FREE YLW, 1115051105. SHUR FINE 12/12OZ AMER FAT FREE YLW, 1116146131. HAGGEN 12/12OZ AMER FAT FREE YLW, 269845607.5 FOODDCLUB 12/12OZ AMER FAT FREE YLW, 368004543.2. EVERYDAY 12/10.7OZ FF IWS AMER PROC YLW, 4130300847. BORDEN 12/12OZ AMER FAT FREE YLW, 5300000675. HYVEE 12/12OZ FAT FREE AMER, 7545009328. BRKSHIRE 12/12OZ AMER FAT FREE YLW, 9282510103.
Imitation Pasteurized Process Cheese Food: SANDWICH MATE 24/6.56OZ IMITATION WHITE, 7103026288. VALU TIME 12/10.67 OZ AMER IMITATION WHITE, 1122509215. SANDWICH MATE 12/8OZ AMER IMITATION PASTEURIZED PROCCESS.99 WHITE, 7103025055.
American Pasteurized Cheese Product: MARVELLA 12OZ 340G AMERICAN PASTEURIZED CHEESE, SINGLES, 5193319275.
Flavored Pasteurized Prepared Cheese Product: HYVEE 12/12OZ PEPPER JACK CHS PROD, 7545009334.
FLAVORED PASTEURIZED PREPARED CHEESE PRODUCT BORDEN SENSATIONS 12/8OZ APPLEWOOD BACON CHEDDAR 5300000980
Non-Fat Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ AMER FAT FREE YELLOW, 3680045432. SHOPPRITE 12/12OZ AMER FAT FREE YLW, 4119045837. MEIJER 12/12 OZ AMERICAN FAT FREE COLOR, 4125056702. SCHNUCKS 12/12OZ AMER FAT FREE YLW, 4131858109.
Swiss Style Cheese Alternative: LISANATTI FOODS, SOY- SATION 12/8OZ SWISS STYLE SLICES, 4529680255.
White Cheddar Flavor Cheese Alternative: SOYA KAAS 12/8OZ WHITE CHEDDAR FLAVOR SLICES, 7801600478.
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2% SHARP CHEDDAR YELLOW, 5300000615.
American Cheddar Flavor Slices: SOYA KAAS 12/8OZ AMERICAN CHEDDAR FLAVOR SLICES, 7801600480.
Reduced Fat Pasteurized Prepared Cheese Product: MEIJER 12/12OZ 2PCT AMER YLW,4125005136. ESSENTIAL EVERYDAY 12/10.7 OZ 2% AMER PROC YLW, 4130300844. BORDEN 12/6.56OZ 2% AMER YLW, 5300000605. BORDEN 12/10.67OZ 2% AMER SINGLES,2.99, 5300000693. HARRIS TEETER 12/12OZ 2% AMER YLW, 7203660084.
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2% PEPPER JACK WHITE, 5300000619.
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/6.56OZ 2% LIGHT MOZZARELLA REDUCED FAT SLICES, 5300001605.
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2PCT AMER WHT, 5300001614.
SHOP RITE 12/12OZ AMER NON-FAT WHITE, 4119045823
Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ SINGLES AMERICAN CHEESE PRODUCT YLW, 3680047752. BORDEN BL 12/6OZ AMER CHS PROD YLW, 6317500640 BORDEN 24/4.37 OZ AMER CHS PROD YLW, 5300000330. BORDEN 24/6.56OZ AMER CHS PROD YLW, 5300000350. BORDEN 12/13.12OZ AMER CHS PROD YLW 1, 5300000370. BORDEN 24/6OZ AMER CHS PROD YLW, 5300000566. BORDEN 12/12OZ HT AMER CHS PRODUCT COLOR(YLW), 5300000636.
Pasteurized Prepared Cheese Product: BORDEN 12/12OZ WHITE AMER CHEESE PROD , 5300001636. CUMBERLAND 12/8OZ AMER CHEESE PROD WHITE, 4270401171
Pasteurized Prepared Cheese Product: .BORDEN 12/10.67OZ GRILLED CHEESE MELTS YLW PP2.99, 5300000429. BORDEN 12/12OZ GRILLED CHEESE MELTS YLW, 5300000436. BORDEN 48/12 OZ GRILLED CHEESE MELTS , 5300000436.
Pasteurized Prepared Cheese Product: BORDEN 12/8OZ SWISS SINGLES CHEESE PROD WHT, 5300000682.
Pasteurized Prepared Cheese Product: BORDEN 12/8OZ LACTOSE FREE AMER YLW, 5300000902.
Pasteurized Prepared Cheese Product: SENSATIONS 12/8OZ SOUTHWEST PEPPER JACK WHT, 5300000990.
Pasteurized Prepared Cheese Product: BORDEN 12/13.12OZ DTT AMERICAN CHEDDAR PROD, 45110155767.3 .
Pasteurized Prepared Cheese Product: FOOD CLUB 12/12 OZ CHEEZY DOES IT, PASTEURIZED PREPARED CHEESE PRODUCT, 3680032338.
Flavored Pasteurized Prepared Cheese Product: MEIJER 12/12OZ MONTEREY PEPPER JACK SINGLES PASTEURIZED PREPARED CHEESE PRODUCT,1928313223.
Flavored Pasteurized Prepared Cheese Product: COBURN FARMS 12/12OZ SINGLES PEPPER JACK WHT,.5193315780.
American Pasteurized Cheese Product: VALU TIME 12/12OZ AMERICAN SLICES CHEESE PRODUCT YLW, 1122502996.
Imitation Pasteurized Process Cheese Food: VALUE TIME 12/8OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122509140. VALUE TIME 12/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122558045. VALUE TIME 48/10.67OZ AMER IMIT YLW DS, 1122558045. CLEAR VALUE 48/10.67 OZ SANDWICH SLICES IMITATION PASTEURIZED PROC EES CHEESE FOOD AMER IMIT YLW, 3680012151. CLER VALUE 12/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD ,AMER IMIT YLW, 3680012151. CLEAR VALUE 48/8OZ AMER IMIT YLW DS, 3680028619. LYNDER 36/10.67OZ IMITATION American singles, AMER IMIT YLW DS, 4149819363. FIESTA 36/16 SINGLES IMITATION PASTEURIZED PROCESS CHEESE FOOD AMER IMIT YLW DS, 5102240005. FIESTA 48/10.67OZ SINGLES, IMITATION PASTEURIZED PROCESS CHEESE FOOD AMER IMIT YLW DS, 5102240006. MCCLARYS 36/10.67OZ SINGLES AMERICAN SANDWICH SLICES, AMER IMIT YLW DS, 5193305332. S-MART 48/302 AMERICANO, AMER IMIT YLW DS, 6057110062. SANDWICH MATE 12/8OZ SINGLES, AMER IMIT PP.99 YLW, 7103025050. SANDWICH MATE 48/8OZ DS AMER IMIT PP.99 YLW, 7103025050. SANDWICH MATE 12/8OZ AMER IMIT PP1.29 YLW, 7103025052. SANDWICH MATE 48/8OZ AMER IMIT PP1.29 YLW DS, 7103025052. SANDWICH MATE 12/10.67OZ AMER IMIT YLW, 7103025162. SANDWICH MATE 12/8.75 OZ AMER IMIT YLW, 7103025253. SANDWICH MATE 12/8OZ AMER IMIT YLW, 7103025260. SANDWICH MATE 36/4.37 OZ AMER IMT YLW, 710302526.8 FISHER 36/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD AMER IMIT YLW DS, 7103025278. SANDWICH MATE 24/6.56OZ AMER IMT YLW, 7103025288.
Imitation Pasteurized Process Cheese Food: BORDEN SUCREM 12/16.4OZ SANDWICH SLICES, AMER IMIT, 451101550735. COUNTRY FARE 12/10.67OZ AMERICAN SANDWICH SLICES, IMIT SINGLE, 7545089000
Imitation Pasteurized Process Cheese Food: SANDWICH MATE 12/10.67OZ SINGLES, SWISS IMIT WHT, 7103025172. VALU TIME 12/10.67OZ SWISS Flavored sandwich slices, IMIT WHT, 1122502481. Sandwich MATE 12/8OZ SWISS flavor singles, IMIT PP.99 WHT, 7103025175
Imitation Pasteurized Process Cheese Food: . Sandwich MATE 12/10.67OZ Monterey JACK singles, IMIT WHT. 7103025182. Sandwich MATE 12/8OZ Monterey JACK singles, IMIT PP.99 WHT, 7103025185
Fat Free Pasteurized Prepared Cheese Product: BORDEN 12/12OZ SHARP CHEDDAR FAT FREE YLW, 5300000678.
Fat Free Pasteurized Prepared Cheese Product: ESSENTIAL EVERYDAY 12/10.7OZ SINGLES WHITE AMERICAN, FF IWS AMER PROC WHT, 4130300848. BORDEN 12/12OZ AMERICAN FAT FREE WHT, 5300001675.
Fat Free Pasteurized Prepared Cheese Product: HYVEE 12/12OZ FAT FREE SWISS CHS, 7545009327. BORDEN 12/12OZ SWISS FAT FREE WHT, 5300000679.
Fat Free Pasteurized Prepared Cheese Product: BORDEN 12/12OZ FF PEPPER JACK WHT, 5300000680..
OxySure Model 615 disposable replacement cartridges
Invivo Expression MRI Patient Monitoring System.
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Potential missing segments on the display that can result in misinterpretation of data.
goodies by Nature RAW CASHEWS, NET WT. 9 oz (255g), held in clear plastic tubs, UPC code of 846034010055. Distributed By: Grand BK Corp. 47-08 Grand Ave. Maspeth, NY 11378. Product of India.
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.
Atkins Chocolate Candies 5 ct. cartons - UPC code 637480075558
Atkins Chocolate Peanut Candies 5 ct. Case - UPC code 637480075770
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories
Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple
Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery
Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered
Medical Device Exchange - Auto Suture Endo Universal 65 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories
Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (repackager), Synthes (OEM) Cerclage, fixation
Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations.
Vegetable Chili, 8 oz plastic container, labeled with a green and white label with green and white lettering.
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Clonidine Hydrochloride Tablets, USP, 0.2 mg, 100 count (NDC 53489-216-01) and 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
RACHAEL'S GOURMET Candy Necklaces, Net Wt. 1.95 oz.; UPC: 0-77449-50452-9
Blood Grouping Reagent, Anti-D (Monoclonal IgG Blend) (Formulated for Automated Testing)
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.

Code Info
Brilliance CT 64-channel with Essence technology: Model #728231; Serial #s: 9654, 95130, 95157 & 95504.
Lot #06512078901017, Item #400920. The tissue is placed in a retainer and sealed in a blister pack
All Lots of Product Code N650, N65, N65-1, N65P, N65P-1
Atkins Chocolate Candies, 5 ct. - Cartons, UPC Code 637480075558, Lot Numbers: A5118139439C; A5119139439A, B, C ; A5120139439A; Best Before Date: April 28 2016, April 29, 2016, April 30, 2016
Atkins Chocolate Peanut Candies, 5 ct. - Case, UPC Code 637480075770, Lot Numbers: A5118139439C; A5119139439A, B, C ; A5120139439A; Best Before Date: April 28 2016, April 29, 2016, April 30, 2016
lot number: 70915 The lot code is also the expiration date of the product. (7/9/2015)
The removal affects all devices manufactured and distributed since February 2014.

Reason for Recall
Blood products, collected from ineligible donors, were distributed.
Platelets, lacking assurance of proper leukoreduction, were distributed.
Blood products, associated with invalid testing results, were distributed.
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
Nut Free Pesto is recalled due to a contamination with Listeria monocytogenes.
Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
The following issues were discovered through internal testing: Fast Get Ready incorrectly enabled during service procedures. Contrast annotation incorrectly missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. Tube heat predictor fails to warn of overheat condition for long scans.
G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
There is a potential the sling loops may not stay attached to the carry bar hooks.
Blood products, in which labeling was incorrect and/ or missing information, were distributed.
Blood products, in which the concentration of apheresis products exceeded the maximum limit, were distributed.
Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
Dairy Farmers of America Inc. is recalling a number of cheese products due that a piece of plastic film strip might remain attached to the cheese slice upon peeling the film from the product.
Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.
Blood products, which were labeled with an incorrect volume and incorrect platelet yield, were distributed.
The device's labeling inaccurately indicates ''endotracheal'' as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as esophageal.
Blood product, in which quality control and distribution of product did not meet specifications, was distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Blood product, for which the quality control testing was incomplete, was distributed.
Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data.
Covidien LP is recalling Nellcor OxiMa N-65 Handheld Pulse Oximeter and Nellcor OxiMax N-65 Handheld Pulse Oximeter because of potential missing segments on the display that can result in misinterpretation of data.
Grand BK Corp. recalls Goodies By Nature RAW CASHWES due to Salmonella contamination.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.
The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
Atkins Nutritionals, Inc. is initiating a voluntary recall of a limited quantity of Atkins Chocolate Candies because it may contain sachets of Atkins Peanut Candies.
Atkins Nutritionals, Inc. is initiating a voluntary recall of Cases of Atkins Chocolate Peanut Candies because it may contain Atkins Chocolate Candies that have sachets of Atkins Peanut Candies.
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
Tornier has initiated a voluntary recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jigs boom. Any separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws.
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
A number of complaints were received with the issue of coarse particles in the glazed surface of IPS e.max Ceram restorations. An analysis of the production process revealed that a basic component of the glass contains a higher number of large grain sizes than usual.
The Vegetable Chili contains undeclared milk, an allergen.
All the engraved markings on the distal face of the instruments are mis-oriented by 180. This includes the markings Anterior and Posterior which the surgeon would use to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the anterior/posterior direction is critical to making the proper anterior, posterior, and chamfer cuts to accommodate the femoral implant.
Misbranded Allergenic Extracts were distributed.
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
Potential measurement error on your ACUSON S Family ultrasound system when repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position. of the shear velocity data
Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.
The product contains undeclared FD&C Blue #1, FD&C Red #40, and FD&C Yellow #5. In addition, FD&C Blue # 2 is declared on the label but was not found in the product.
Anti-D Blend Solidscreen II, containg a weak reacting contaminating anitbody, was distributed.
Allergenic Extract, associated with an out of specification stability result for potency, was distributed.
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.