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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000. S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701 Class II It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the mating SI50002 Implant Holder can shear off under high-impact force during insertion and removal. SpineFrontier, Inc.
Drugs Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 a) Liptruzet 10/10mg, 30 count, 346380,353183, Exp. 07/14 b) Liptruzet 10/10mg, 90 count 346381, 350264, Exp 07/14; 357235, Exp. 12/14. Class III Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. Merck & Co Inc
Drugs Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 a) Liptruzet 10/20mg 30 count, 346353, 346354, Exp. 06/14; 351809, Exp. 07/14, 360530, Exp. 12/14. b) Liptruzet 10/20mg, 90 count, 346387, Exp. 06/14; 353185, Exp.12/14. Class III Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. Merck & Co Inc
Drugs Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 a) Liptruzet 10/40mg 30 count, 346304, 346342, 350256, 353107, 353108, 353109, Exp. 06/14; 353110, Exp.12/14 b) Liptruzet 10/40mg 90 count 346382, Exp. 06/14; 353186, Exp.12/14. Class III Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. Merck & Co Inc
Drugs Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 a) Liptruzet 10/80mg 30 count, 346379, 350257, Exp.07/14; 353591, Exp. 06/15. b) Liptruzet 10/80mg 90 count, 346383, 371072, Exp. 06/15. Class III Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. Merck & Co Inc
Veterinary Cattlyst 50G is a Type A Medicated Article packaged in 50 lb (22.68 kg) multiwall paper bag with protective barrier ply. Lot Number: HC220009; Expiries: October 2015 Class III Lot HC220009 was mislabeled with the manufacturing date and the expiration dates inverted. Zoetis Inc
Devices ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb. All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb. Class II Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling. Siemens Healthcare Diagnostics
Devices Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation. Product Code 1154654 - Lot 02K0801212 Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation. Product Code 0100019-507 -Lot 02F1301128, Product Code 6-511 - Lot 02M0800561, Product Code 6-559 - Lot 02A0800005, Product Code 69-403 - Lot 02H0802530, Product Code 7-5008M4 - Lot 02C0900466, Product Code 7-518 - Lot 02E1302561, Product Code 7-565 - Lot 02B1100185, Product Code 7-655A - Lot 02C0901963, Product Code 7-655A - Lot 02M0800836, Product Code 7-740 - Lot 02L1000536, Product Code 833-114 - Lot 02A1202112, 02C0902841, 02C0903374, 02D1202794, 02F0902697, 02K1100404, 02L1202369, 02M0802509, Product Code E13-6351 - Lot 02F0902446, Product Code E13-6354 - Lot 02F0902439, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594 Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation. Product Code 833-123 - Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309, Product Code 833-124 - Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322, Product Code 833-213 - Lot 02H1100687, Product Code D-5007K - Lot 02B1002310, 02C1103731, 02F1100069, 02H1102294, Product Code D-5007M4A - Lot 02M0902844, Product Code D-5007M4K - Lot 02C1002252, 02F1100124, Product Code D-7016M4K - Lot 02G1301749, Product Code D-7070K - Lot 02A1103450, 02B1002276, Product Code D-7070M4K - Lot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010, Product Code D-7076M1K - Lot 02H1103237, Product Code D-7375K - Lot 02A1201015, Product Code D-793M4K - Lot 02L1002488, Product Code ED-6072 - Lot 02C1002218, 02E1002342, 02J0902517, Product Code ED-6276 - Lot 02F0902457, Product Code ED-6896 - Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755, Product Code ED-852 - Lot 02G1002594, Product Code ED-863 - Lot 02B0902976, 02D0902457, 02M0901348. Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation. Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137 Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation. Product Code H5300 - Lot 1450153E13 Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. Product Code X-4981M4 - Lot 02J0800451 Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation. Product Code X-6371M5 - Lot 02E0801603 Class II Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. Teleflex Medical
Devices Medtronic SynchroMed® II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter. This Medical Device Correction notification affects all SynchroMed II pumps. Class II This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. This communication is based on information available to date and was developed in collaboration with clinical experts. Medtronic continues to investigate this issue and we are committed to providing updates as more information becomes available. Medtronic Neuromodulation
Drugs Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05 Lot # 13E0008F3P8V; Exp. 03/15 Class II Defective container: Product distributed without inner seal on bottles. Blu Pharmaceuticals Inc
Drugs Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05 Lot # 13E0014F1P8V; Exp. 04/15 Class II Defective container: Product distributed without inner seal on bottles. Blu Pharmaceuticals Inc
Biologics Red Blood Cells Leukocytes Reduced W038314013506; Class II Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Irradiated W200613136260; Class II Blood products, possibly contaminated by air during collection, were distributed. American National Red Cross The
Biologics Plasma Frozen within 24 hours (FP24) W200613136251; W200613136252; W200613136255; W200613136257; W200613136260; W200613136261; W200613136266; W200613157676; Class II Blood products, possibly contaminated by air during collection, were distributed. American National Red Cross The
Biologics Red Blood Cells Leukocytes Reduced W200613136251; W200613136252; W200613136255; W200613136257; W200613136261; W200613136263; W200613136266; W200613157676; W200613157689; W200613157692; W200613175963; W200613175967; W200613175976; W200613175977; W200613175980; Class II Blood products, possibly contaminated by air during collection, were distributed. American National Red Cross The
Biologics Blood and Blood Products for Reprocessing W200613136253; W200613136263; W200613157689; W200613157692; W200613175963; W200613175967; W200613175976; W200613175977; W200613175980; W200613175981; Class III Blood products, possibly contaminated by air during collection, were distributed. American National Red Cross The
Biologics Platelets Pheresis W20221380044100; Class II Blood product, inappropriately stored in one platelet bag instead of two, was distributed. American National Red Cross, Penn Jersey Region
Devices Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems Kit Lots ending in and exp date: 219 Exp. Date 25 March, 2014; 222 Exp Date 12 May, 2014; 224 Exp Date 04 August, 2014; 225 Exp Date 04 August, 2014; 226 Exp Date 12 September, 2014; 227 Exp. Date 06 October, 2014 Class II Serum controls may go out of range low with the ADVIA Centaur ®Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223 Siemens Healthcare Diagnostics, Inc
Devices RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. Model 762: 300000-300191 Model 763: 200000 Model 763A: 400000-40103 Class II All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring. Med-Mizer, Inc.
Devices RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. Serial Number 2000 Class II All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring. Med-Mizer, Inc.
Devices RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. Model 801 : 50000-50018; Model 802n : 600000-600789 Model 803: 500000-500342; 803A 700000-701724 Class II All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring. Med-Mizer, Inc.
Biologics Red Blood Cells W0368098152202 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036808193925 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Plasma Cryoprecipitated Reduced W036808152202 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037914115459; Class III Blood product, collected from a donor whose arm inspection was not documented, was distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W203414023027; W203414023027; Class II Blood products, collected in a manner that compromised the sterility of the units, were distributed. American National Red Cross ARC Blood Services N.E. Region
Devices Alere Triage® BNP Test For the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage® BNP test is a two-site immunoenzymatic (sandwich) assay. A sample is added to a reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts specifically with bound BNP. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate, Lumi- Phos* 530, is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BNP in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve. The Alere TriageR BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: · as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) · as an aid in the assessment of severity of congestive heart failure · for the risk stratification of patients with acute coronary syndromes · for the risk stratification of patients with heart failure Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14 Class II Alere San Diego, Inc. initiated recall of Alere Triage® BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Lots 329599 and 331265, because these lots may not recover within range when tested using certain commercially available controls. Alere San Diego, Inc.
Food the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Sourdough Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Wheat Sourdough 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Flaxseed Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Food the BREAD STOP Spelt and Millet Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled. Class III An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling. Bread Stop Bakery, LLC
Devices Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001 Class II Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances. Shimadzu Medical Systems
Drugs Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25 Lot 261983A Exp.11/15 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. Boehringer Ingelheim Roxane Inc
Drugs Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11 Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. Boehringer Ingelheim Roxane Inc
Devices CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. Serial Number: 212809 Class III Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. Siemens Healthcare Diagnostics Inc
Drugs Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1. Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15 Class II Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. Wockhardt Usa Inc.
Devices INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306. Class II An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater than 200 ppm/25 ppm respectively over a 10 second period. INO Therapeutics (dba Ikaria)
Food Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. "point of purchase" display case. UPC 846107009785 (individual unit UPC 846107009788) Product number 16593. Bissinger's Handcrafted Chocolatier, St. Louis, MO. Lot Codes: 4981 Best By FEB 2015 Class I Milk chocolate bunny ears are packaged in dark chocolate packaging. The ingredient statement does not list milk. Karl Bissinger LLC
Devices AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender. Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621. Class II The donor was hemodiluted. AlloSource, Inc.
Food Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618 Printed on the edge lid code: L13-102 BEST BY: 12OCT2014 Class I Product contains undeclared peanut protein Sinco Inc.
Devices Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin. Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015 Class II There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used. Bio-Rad Laboratories, Inc.
Food PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: "INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15 3948 00:48 LIA" 0 11110 52108 8 SELL BY AUG 11 15 3948 Class I The firm was notified of the presence of undeclared milk in the product. Kroger Co
Devices Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014. Class II Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue. Medtronic Neuromodulation
Devices Product Brand Name: Alere INRatio®2 PT/INR Professional Test Strips Model Number: 99008G2 Product Usage: Usage: Indications for use: The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Limitations: The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. Lot/Unit Codes: Applicable to all Alere INRatio®2 PT/INR Professional Test Strips lots packaged from 8/22/13 through 3/28/14, including the following: 324810, 324811, 324812, 327543, 327544, 327549, 328109, 328705, 328707, 330238, 330852, 331340, 331916, 331922, 332841, 332842, 332843, 332959, 333362, 333654, 333655, 333864, 333865, 334572, 334575, 335552, 335553, 335796, 335797, 336426, 336668, 337350, 338965, 338966, 339257, 339707, 327856V Expiration date, or Expected shelf life: range from 4/30/14 to 1/31/15 Class I Alere San Diego is initiating a voluntary recall for the Alere INRatio®2 PT/INR Professional Test Strips. This action is being initiated as a result of several complaints of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio®2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere San Diego, Inc.
Devices 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process. Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1, 48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1, 36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129, 43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476, 43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542, 41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1, 51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1, 37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1, 48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445, 42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843, 42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610, 43893-1-13, 39219, 43893-1-2, 43893-1-14. Class II Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing. Stryker Endoscopy
Devices Giraffe® Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). HDJM50062 HDJM50093 HDJM50470 HDJM50654 HDJM51812 HDJS55099 HDJS53396 HDJS53397 HDJS53398 HDJT50393 HDJS55036 HDJS55037 HDJS55038 HDJT50318 HDJS52165 HDJS52166 HDJS52119 HDJS52120 HDJR57563 HDJR57564 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJS50733 HDJS52092 HDJS52093 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJS51006 HDJP50601 HDJP50606 HDJN50376 HDJS50790 HDJS50791 HDJS50792 HDJS50159 HDJS50160 HDJS51426 HDJS51427 HDJS50734 HDJS50735 HDJS52118 HDJT50534 HDJT50039 HDJR58198 HDJS50316 Class II Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. GE Healthcare
Devices Panda® iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). 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HDJS51960 HDJS51961 HDJS51962 HDJS53441 HDJS53442 HDJS53461 HDJS51738 HDJS50473 HDJS50627 HDJS50631 HDJS50646 HDJS50647 HDJS50713 HDJS50714 HDJS50716 HDJS50719 HDJS50720 HDJS51151 HDJS53147 HDJS53148 HDJS53462 HDJS53463 HDJS53464 Class II Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. GE Healthcare
Devices Panda® Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979 Class II Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. GE Healthcare
Devices Panda® Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804 Class II Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. GE Healthcare
Devices Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). BS9SEN BS9SES BSAVX8 BSAVX9 BSAW3A BSAY0P BSAY0U BSAY15 BSAY18 BSAY1A BSAY1E BSAY1F BSAY1N BSAY1U BSAY1X BSAY3C BSAY3F BSAY3N BSAY3V BSAY3X BSAY5D BSAY5H BSAY8S BSAY9C BSAY9G BSAY9J BSAY9R BSAYAR BSAYAU BSAYB1 BSAYBW BSAYBX BSAYC3 BSAYC9 BSAYCB BSAYCC BSAYCD BSAYGV BSAYGX BSAYGY BSAYGZ BSAYH0 BSAYH4 BSAYH6 BSAYIG BSAYJC BSAYJD BSAYOW BSAYOZ BSAYPM BSAYPU BSAYR5 BSAYSA BSAYSJ BSB993 BSB9AG BSB9AJ BSB9AR BSB9AX BSB9B9 BSB9BD BSB9BE BSB9BK BSB9D6 BSB9D7 BSB9DB BSB9DE BSB9JK BSB9JU BSB9KG BSB9KU BSB9KY BSB9NW BSB9NX BSB9NY BSB9NZ BSB9P3 BSB9P6 BSB9PA BSB9PE BSB9PG BSB9PK BSB9PL BSB9PR BSB9PY BSB9R0 BSB9R3 BSB9R5 BSB9R7 BSB9R9 BSB9RC BSB9RL BSB9RY BSB9RZ BSB9S2 BSB9S3 BSB9S5 BSB9SJ BSB9SY BSB9SZ BSB9T4 BSB9T8 BSB9TA BSB9TD BSB9TG BSB9TJ BSB9TM BSB9TS bsb9tu BSB9TX BSB9TZ BSB9U1 BSB9X6 BSB9X7 BSB9X8 BSB9X9 BSB9XA BSB9XF BSB9XG BSB9XR BSB9XX BSB9Y6 BSB9Y7 BSB9YB BSBCUJ BSBCUS BSBCV1 BSBCV2 BSBCVB BSBCWP BSBOTA BSBOTE BSBOU2 BSBOU8 BSBPTL BSBXTL BSBXTT BSBXTX BSBXU1 BSBXUO BSCE5J BSCEC4 BSCEC5 BSCEC6 BSCEE5 BSCEEC BSCEED BSCEEF BSCEEH BSCEEJ BSCEEW BSCEHH BSCEHN BSCEHR BSCEHW BSCEHX BSCEHZ BSCEKP BSCEKT BSCEKV BSCM9V BSCMA8 BSCMA9 BSCMAD BSCZPT BSCZPU BSCZPW BSCZPY BSCZR6 BSCZR7 BSCZR9 BSCZRC BSCZRO BSCZRP BSCZRW BSD0B1 BSDOAK BSDOAT BSDOAU BSDOAY BSDOAZ BSEJGJ BSA41K BSAY0K BSAY21 BSAYA0 BSAYBC BSAYBH BSAYBN BSB9PX BSB9RR BSB9SB BSB9TH BSB9SA BSB9AV BSBCV5 BSCZRJ BSCZRY Class II Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. GE Healthcare
Devices TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue. Lot Numbers: 00614-03, 06513-02, 24913-01, 00713-06, 06514-02, 25313-01, 00814-02, 06914-01, 25513-02, 01114-02, 07213-04, 25613-01, 01514-03, 07713-18, 26113-06, 01714-04, 08113-04, 26313-04, 01813-02, 08413-13, 26713-04, 02314-08, 09313-05, 26813-01, 02413-04, 10213-07, 27013-10, 02714-02, 10613-01, 27613-02, 02914-01, 11213-07, 28013-05, 03014-02, 11613-06, 28313-02, 03113-02, 12113-02, 29513-03, 03114-02, 12713-03, 29713-01, 03414-03, 13413-01, 30913-07, 03514-05, 14413-05, 31113-08, 03714-03, 15013-04, 31513-02, 03814-06, 15413-02, 31713-05, 04114-02, 15413-03, 32213-01, 04213-01, 16513-04, 32413-01, 04214-05, 17013-02, 32613-01, 04414-03, 17013-09, 32913-07, 04514-02, 17613-08, 33613-09, 04814-07, 17913-16, 33813-05, 05014-02, 18413-05, 34013-03, 05113-01, 18413-06, 34313-01, 05113-02, 18613-03, 34413-04, 05114-09, 19213-03, 34513-04, 05514-01, 19713-04, 34713-08, 05614-04, 20713-06, 35113-01, 05713-03, 21813-01, 35213-03, 05714-10, 23913-01, 36013-01, 06313-05, 24113-04, 36113-02, 06314-04, 24213-04, and 36413-05. Class II The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact. Tenex Health Inc
Food Scale label printed with "EASTER BREAD NET WT 17oz (1.06lb)" UPC 0 77890 32431 8, packaged in clear plastic bag UPC 0 77890 32431 8 all Sell By dates (between 3/27/14 and 4/22/14) Class II Wegmans Food Markets, Inc. has initiated a voluntary recall of all Wegmans Easter Bread (braided loaf) 17 oz., UPC 0 77890 32431 8 (all code dates) because it contains egg, which are not declared on the label. Wegmans Food Markets, Inc.
Devices Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery. Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03) Class II The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component. Biorep Technologies
Devices Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile. Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743. Class II Out of specification results for one of the two disinfectants. Bausch & Lomb Inc- Greenville Solutions Plant
Cosmetics Medline Skintegrity Moisturizing Lotion, made with oatmeal, aloe & vitamin e, 2 & 4 oz btls, Manufactured in USA for Medline Industries, Inc., Mundelein, IL 60060 UPC 0 80196 75401 7 2 oz - Catalog #MSC098502, Lot #: (L)12090411 & 4 oz -Catalog #MSC098504, Lot #: (L)12120509 Class II Kutol Products Company is voluntarily recalling the affected products as they were found to be out of specification for Aerobic Plate Count and presence of gram negative bacteria. Specification for Aerobic Plate Count is < 100 cfu per gram with results for both affected product lots being Too Numerous To Count (TNTC). Specification for gram negative bacteria is "negative" with results for both affected product lots being "positive" for gram negative bacteria. The gram negative bacteria was identified as pseudomonas aeruginosa. Kutol Products Co
Food Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala Lot # 2161100811 Class III Unapproved fungicide residue detected on random sample. Carbendizam at 28 ppb Harvest Sensations LLC
Devices Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients. 1301273 1302515 1303486 1304517 1305636 1306626 1307463 1308631 1309375 1301350 1302516 1303487 1304571 1305711 1306666 1307536 1308665 1309437 1301453 1302600 1303559 1304660 1305782 1306666 1307758 1308666 1309532 1301456 1302634 1303560 1304662 1305840 1306718 1307759 1308722 1309566 1301514 1302655 1303680 1304750 1305907 1306722 1307841 1308799 1309589 1301580 1302675 1303722 1304794 1305953 1306810 1307842 1308821 1309592 1301682 1302703 1303728 1304851 1305954 1306834 1307857 1308830 1309613 1301705 1302714 1303776 1304962 1306107 1306844 1307897 1308833 1309647 1301751 1302791 1303839 1305045 1306108 1306897 1307904 1308981 1309662 1301898 1302809 1303840 1305108 1306110 1306913 1308035 1309027 1309717 1301966 1302852 1303876 1305142 1306225 1307022 1308052 1309029 1309743 1301972 1302933 1303943 1305176 1306228 1307041 1308059 1309120 1309765 1302063 1302934 1303977 1305193 1306299 1307041 1308201 1309123 1309807 1302074 1302993 1304027 1305234 1306307 1307042 1308202 1309139 1309860 1302115 1302994 1304112 1305303 1306308 1307095 1308217 1309206 1309890 1302195 1303055 1304158 1305341 1306377 1307219 1308279 1309227 1309904 1302266 1303144 1304176 1305342 1306411 1307230 1308294 1309241 1309923 1302269 1303178 1304235 1305379 1306465 1307276 1308335 1309280 1309926 1302319 1303231 1304286 1305472 1306467 1307317 1308384 1309283 1309983 1302337 1303232 1304428 1305523 1306544 1307391 1308443 1309327 1310113 1302461 1303322 1304440 1305632 1306599 1307413 1308520 1309364 1310147 1302485 1303391 1304454 1305633 1306610 1307418 1308533 1309374 Class II Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water. Mar Cor Purification
Biologics Hepatitis B Vaccine (Recombinant) J001183 Class II Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed. Merck Sharpe & Dohme Corp
Drugs Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703. Lot Code: 13348 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti
Drugs Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 . Lot Code: 13348 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti
Drugs Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Lot Code: 13350 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti
Drugs Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Lot Code: 13350 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti
Drugs Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Lot Code: 13350 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti
Drugs Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Lot Code: 13351 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. Mangiacotti
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