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U.S. Department of Health and Human Services

Enforcement Report - Week of October 1, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Dan Nelson Dairy Pre-mix R Dairy mineral pre-mix with Monensin at 509g/ton Product #WIK361 Lot #21413J On product tag - WIK361 Lot #21413J Class I Custom blend of mineral pre-mix was found with high levels of monensin up from 800 g/ton to 26,000 g/ton Renaissance Nutrition, Inc.
Devices 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 Class II Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. Instratek, Incorporated
Veterinary 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) Class I 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). Mercer Milling Co. Inc.
Veterinary 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) Class III Private lab analysis of stock mix revealed monensin at 34% of label claim (sub-potent). Mercer Milling Co. Inc.
Devices 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. Class II 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. Genesys Orthopedics Systems, LLC
Devices EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 Part number 9079-VC-005; lot code 3606455 Class II The voluntary recall is due to the needle set not meeting its specifications. Vidacare Corporation
Biologics Genzyme Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], 25 mg (NDC 58468-0080-01) Lot Number C1280C01 C1286C02 Class III 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. Genzyme, A Sanofi Company
Biologics 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 13BOKC7112 13BOKC6840 13BOKC5654 13BOKB8431 13BOKB4062 13BOKB3793 13BOKB2336 13BOKB1805 13BOKB1966 13BOKB1783 13BOKB1891 13BOKB1844 13BOKB2016 13BOKB1922 13BOKB1899 13BOKB1632 13BOKB1522 13BOKB1665 13BOKB1764 13BOKB1646 13BOKB1652 13BOKB1758 13BOKB1526 13BOKB1686 13BOKB1574 13BOKB1678 13BOKB1671 13BOKB1384 13BOKB1501 13BOKB1442 13BOKB1331 13BOKB1367 13BOKB1494 13BOKB1327 13BOKB1425 13BOKB1270 13BOKB1131 13BOKB1027 13BOKB1013 13BOKB1040 13BOKB1033 13BOKB1290 13BOKB1214 13BOKB0842 13BOKB0775 13BOKB1007 13BOKB0845 13BOKB0808 13BOKB0955 13BOKB0851  ...
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Class II Source Plasma, collected from ineligible donors, were distributed. BioLife Plasma Services L.P.
Food 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 Class II Printing error by the packaging manufacturer erroneously added a "GF" symbol to the packages. Frito-Lay, Inc
Devices eye-pak 7407 Tray Support Cover REF 8065740745 Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V. Class II The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. Alcon Research, Ltd.
Devices The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm) Class II UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. Argon Medical Devices, Inc
Devices The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm) Class II UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. Argon Medical Devices, Inc
Devices 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. Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) Class II UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. Argon Medical Devices, Inc
Biologics Red Blood Cells W050911075480 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Irradiated W0050911079224 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Devices 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. Model Numbers: HMA0002 and HMB002-US; Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531 Class II 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. ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Biologics Red Blood Cells Leukocytes Reduced W204114011757 Class II Misbranded RBCs were distributed. American Red Cross Blood Services
Devices 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 material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959 Class II 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. Siemens Medical Solutions USA, Inc
Biologics Source Plasma 2820768357 Class II Blood product, collected from a donor who had been incarcerated, was distributed. Grifols PlasmaCare, Inc.
Food Dehydrated minced green onion sold under the Silva brand and packaged in 28 lb. box. Item No.: 90S; Lot No.: 05091490S-28 Class I Silva International Inc. is a lot of recalling Minced Green Onion, "Irradiated" due to reported Salmonella contamination. Silva International, Inc.
Biologics Red Blood Cells Leukocytes Reduced W0352111169400 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Biologics Cryoprecipitated AHF W0352111169400 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W0352111169400 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Biologics 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  ...
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Class III ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed. Celera Corporation
Food 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 UPC 85370100401, Lot A14314, Exp. 05/23/2015 Class I Product may be contaminated with Salmonella. Oriya Organics
Devices Artis zee and Artis zeego systems. x-ray, angiographic system running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers . Class II 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. Siemens Medical Solutions USA, Inc
Devices 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  ...
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Class II A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. Peters Surgical
Devices 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). 1) Item reference: 73P20B , Batch number: 1902 , Expiration date: 09/2018  ...
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Class II A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. Peters Surgical
Biologics Red Blood Cells Leukocytes Reduced W3985140023394; W398514001687H Class III Blood products, collected from a donor for whom there was no record of an arm inspection, were distributed. Community Blood Center of Carolinas
Biologics Platelets Pooled Leukocytes Reduced W398614000504B Class III Blood products, collected from a donor for whom there was no record of an arm inspection, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W398514003462J Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Center of Carolinas
Biologics Platelets Pheresis Leukocytes Reduced W398514001266M; W3985140531318 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Center of Carolinas
Biologics Fresh Frozen Plasma W398514003462J Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036914853460; W036914208922; W036914853601; W036914853332 Class III Blood products, labeled with incorrect expiration dates, were distributed. Blood Bank Of Delmarva, Inc
Biologics Terumo BCT Lake wood, CO 80215, Catalog No 61000 Spectra Optima Apheresis System, Country of Origin: US. Catalog number 61000 (all serial numbers) Class III 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. Terumo BCT, Inc.
Food 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 Code 226F, Best by 08OCT2015 Class II Found to have levels of inorganic arsenic that exceeds FDA levels of concern limits. Florida Bottling, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W042214015569N Class III Blood product, labeled with an incorrect expiration date, was distributed. United Blood Services
Biologics Platelets Pheresis Leukocytes Reduced W043214048230 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced 1388248 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 W203414010276 Class III Blood product, which was labeled with an incorrect expiration date, was distributed. Arc Blood Services, New England Region
Biologics Platelets Pheresis Leukocytes Reduced W115114109743B Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers Inc
Biologics Red Blood Cells W087614561470 Class III Blood product, labeled with an incorrect expiration date, was distributed. Virginia Blood Services
Biologics 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 CAT #402504F Lot # 997024327; 997024637; 997025300 Class III Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. Genesis BPS, LLC.
Biologics 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 CAT #402504 Lot # 968023365; 968024880; 968024326; 968024586 Class III Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. Genesis BPS, LLC.
Biologics 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 CAT #402524 Lot# 998024328 Class III Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. Genesis BPS, LLC.
Biologics 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 CAT #402501 Lot # 967024879; 967024325; 967024585 Class III Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. Genesis BPS, LLC.
Biologics Red Blood Cells Leukocytes Reduced W290614054949 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Penrose-St Francis Health Services Blood Bank
Food 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 2011 LOT/EXP DATE: 3461106 -12/2014, 3431106 -12/2014, 3411106 -12/2014, 3201106 - 11/2014, 3191106 - 11/2014, 3141106 - 11/2014, 2991106 - 11/2014, 2711106 - 10/2014, 2571106 - 09/2014, 2561106 - 09/2014, 2351106 - 09/2014, 2221106 - 08/2014, 2091106 - 07/2014, 1941106 - 07/2014, 1801106 - 06/2014. 2012 LOT/EXP DATE: 3541206 -  ...
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Class II 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. Arise & Shine Herbal Products, Inc.
Food Tunas Turkish Delight Rose Flavored, Net Wt. 14.11 oz., US Importer and Distributor: Turkana Food, Inc., Exporter: Tunas Food Industry, UPC 86925940080 None Class III Tunas Turkish Delight Rose Flavored contains Ponceau 4R which is an unapproved color in the US. Turkana Food Inc.
Food Boku Super Protein 3.0, Product Sizes: 21.2 oz, 1 oz., bulk. Lot No. FM05071014A, FM05070714A, FM05062314B, FM05062314A, FM05062014A, FM05070314A. Class I Boku is recalling Super Protein because it may be contaminated with Salmonella. BoKU International
Food Boku Super Food 2.0, Product Sizes: 28.2 oz Lot No. FM01070214A, FM01072114A Class I Boku is recalling Super Food because it may be contaminated with Salmonella. BoKU International
Food Boku Super Food 3.0, Product Sizes: 10 oz. Lot No. FM06070714A Class I Boku is recalling Super Food because it may be contaminated with Salmonella. BoKU International
Food 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 Lot Codes: 14083602, 14083702, 14083602, 13356402, 14083602 and 14157402. BEST IF USED BY 9 2015; BEST IF USED BY 12 2015. Class II Incorrect declaration of allergens. The ingredient label properly lists the wheat allergen but the "Contains" statement does not. Great American Appetizers, Inc.
Devices 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  ...
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Class II 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. Carefusion 2200 Inc
Devices 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.). Lot 9090 (exp. December 15, 2014) Class II 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). ORTHO-CLINICAL DIAGNOSTICS
Devices 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  ...
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Class II Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. Centurion Medical Products Corporation
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated Washed W068514003939 Class II Blood products, possibly contaminated with air, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W068514004236; W068514004236; W068514004249; W068514004249; W068514003939 Class II Blood products, possibly contaminated with air, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W068514004778; W068514004778; W068514004650; W068514004659; W068514004600; W068514004600; W068514004602; W068514004602; W068514004609; W068514004609; W068514004370; W068514004122; W068514004101; W068514004101; W068514004102; W068514004102; W068514004370; W068514004163; W068514004163; W068514004119; W068514004119; W068514004122; W068514003891; W068514003891; W068514003805; W068514003805; Class II Blood products, possibly contaminated with air, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells Leukocytes Reduced W20381409929600 Class II Blood product, possibly contaminated with air, was distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Red Blood Cells Leukocytes Reduced W0352141452119; W035214146310O; W035214124176Q; W035214124196I; W035214233270O; W035214096925E; W035214060814Z Class III Blood products, shipped using coolers that had not been validated and possibly reached unacceptable temperatures, were distributed. Carter BloodCare, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037711205638 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Hoxworth Blood Center
Biologics Blood and Blood Products for Reprocessing W037711205638 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Hoxworth Blood Center
Biologics TerumoBCT, Lakewood, CO 80215 USA. Catalog No: 6100 Spectra Optia Apheresis System Catalog Number: 61000; Serial Number 1P00000 Class III Spectra Optia Apheresis Systems with version 11 software, associated with unexpected behavior regarding rinseback, were distributed. Terumo BCT, Inc.
Drugs 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 Class III Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point Akorn, Inc.
Devices 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. SERIAL # ENVE CUSTOMER UNITS: 26562 44554 44559 45317 45322 45324 45328 45330 45333 45334 45336 45339 45341 45343 45736 45737 45740 45741 45742 45744 45745 45750 45751 45752 45907 45908 46040 46041 46043 46044 46050 46051 46632 46636 46641 46642 46643 46644 46645 46646 47069 47071 47073 47075 47076  ...
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Class I 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. CareFusion 203, Inc.
Devices 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 Class II 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. Nanosphere, Inc.
Devices 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 Class II 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. Nanosphere, Inc.
Devices 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. Product Number: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14 Class II 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. Nanosphere, Inc.
Devices 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+ facility is available to receive and culture specimens. Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14 Class II 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. Nanosphere, Inc.
Devices 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 not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. 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 Class II 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. Nanosphere, Inc.
Devices No packaging. Device is a wheel chair. Fuze T50, Fuze T20 and Fuze T50 Jr Fuze T50, Fuze T20 and Fuze T50 Jr 52752 52794 52750 52667 52679 52692 52729 52745 52779 52826 52865 52878 52823 52912 52804 52666 52680 52702 52731 52746 52780 52827 52866 52879 52749 52913 52753 52669 52682 52703 52732 52747 52781 52828 52867 52880 52696 52796 52734 52670 52681 52695 52735 52768 52782 52856 52868 52881 52748 52705 52701 52671 52683 52707 52736 52770 52802 52857 52869 52882 52825 52699 52698 52672 52684 52708 52737 52771 52803 52858 52870 52883 52829 52706 52834 52668 52685 52710 52738 52772 52805 52859 52871 52884 52916 52751 52821 52673 52687 52709 52739 52773 52806 52860 52872 52885 52767 52799 53192 52674 52690 52711 52740 52774 52807 52861 52873 52886 52795 52914 52663 52676 52688 52726 52741 52775 52808 52862 52874 52887 52919 52824 52664 52677 52691 52728 52742 52776 52809 52863 52876 52888 52831 52918 52665 52675 52693 52727 52743 52777 52810 52864 52877 52889 52754 52917 52733 52678 52694 52730 52744 52778 52811 Class II 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. Pdg Product Design Group Inc
Devices 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. REF #306533 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017 Class II BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306533). Becton Dickinson & Company
Food 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" Class II Although ingredient statement lists "Tamari," Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food 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. Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. "BEST BY: 08/25/14" Class II Although ingredient statement lists "Tamari", Label lacks statement, "Contains Soy." Roots Organic Gourmet
Food Condensed Skim Milk in bulk tanker (approximately 40,000 pounds per tanker load) The Dannon Company: Batch No.'s 1002810163 1002810445 1002810700 1002810745 1002810885 1002811154 1002811681 1002811849 1002811932 Dean Foods: Batch No. 1002812313 Unilever: Batch No. 1002810249 Continental Dairy Facilities, LLC: Load No. 990000000000055717 Class III 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. Dairy Farmers of America
Food Cream (Bulk; approximately 40,000 pounds per tanker load) The Dannon Company: Batch No.'s 1002810163 1002810445 1002810700 1002810745 1002810885 1002811154 1002811681 1002811849 1002811932 Dean Foods: Batch No. 1002812313 Unilever: Batch No. 1002810249 Continental Dairy Facilities, LLC: Load No. 990000000000055717 Class III 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. Dairy Farmers of America
Food Raw Milk (Bulk; approximately 40,000 pounds per tanker load) The Dannon Company: Batch No.'s 1002810163 1002810445 1002810700 1002810745 1002810885 1002811154 1002811681 1002811849 1002811932 Dean Foods: Batch No. 1002812313 Unilever: Batch No. 1002810249 Continental Dairy Facilities, LLC: Load No. 990000000000055717 Class III 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. Dairy Farmers of America
Food Garden Fresh Egg Salad, Code #2022, Net Wt. 5 lbs. (2.268 Kg) UPC 11596-52022 Use By 09121401 Class I Garden Fresh Foods, Inc. is recalling Garden Fresh Egg Salad because it has the potential to be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Devices 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. Lot # 2768416 Class I ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. ICU Medical, Inc.
Devices 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. Lot # 2768417 Class I ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. ICU Medical, Inc.
Devices 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. Lot # 2801951 Class I ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. ICU Medical, Inc.
Devices 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. Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL Class I ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. ICU Medical, Inc.
Devices 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 Class II When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. Philips Medical Systems (Cleveland) Inc
Devices 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). All Lots Class II 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. Horiba Instruments, Inc dba Horiba Medical
Devices 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. Sample probe cables, Lot number 2014. Serial No. 600785 601704 900359 900950 601257 600968 900613 604013 603950 604006 603963 603972 604002 604008 603995 604004 603939 603940 603932 603934 603978 603998 604009 603948 603945 603977 603956 603933 604007 603929 604019 604017 604012 603935 603941 603997 603996 604000 603976 604014 601897 604005 603955 603944 603942 601801 603962 603928 603992 603993 603982 603991 603971 603970 603983 603980 603964 603986 603985 603984 603967 603981 603969 603994 603943 603957 603953 604001 604016 603973 900939 603951 600525 900231 601251 603936 601831 603545 6303547 602589 900913 603859 603860 900368 900935 603078 900782 601493 606694 603693 602113 602595 900933 603917 600571 601220 601265 603013 600794 600306 601718 602771 602782 601925 600758 600857 603007 601658 603717 602020 601894 600891 600882 600980 602036 603539 603706 603975 900940 603999 601510 601381 900947 601624 603946 603949 603947 603952 603016 602996 603974 601509 601513 601928 900834 600931 600693 600511 600341 900264 601969 601109 600113 601791 600959 603931 603966 600680 601305 601872 603503 603125 603915 603988 601255 604003 603965 603989 900851 900826 601984 602278 900765 602356 900581 600343 900948 602313 900057 600912 602360 601828  ...
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Class II 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. Beckman Coulter Inc.
Veterinary 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. Lot # 2758229 and 2785379 Class II ICU is recalling the ConMed Stat2 flow controller because it may deliver a significantly higher flow rate than marked on the controller. ICU Medical, Inc.
Devices 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices 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. 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices 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. 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices 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. 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices 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. 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices 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. 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). Class II Disposable Patient Circuit that allows water to leak into the center gas lumen Vapotherm, Inc.
Devices 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 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). Class II Water may leak into the center gas lumen of the Patient Circuit Vapotherm, Inc.
Food La Orocovena, Pound Cake Queso, NET WT. 2 OZ. (56.7 grams) 08112014 to 101214 (numbers correspond to manufacturing and distribution date) Class I Undeclared allergens: milk, wheat, soy, yellow 5&6 and red 40. La Orocovena Biscuit
Drugs 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. Lot P318220, EXP 05/31/15 Class II Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside. Baxter Healthcare Corp
Devices 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 Class II Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. Smith & Nephew, Inc.
Devices 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. Lot: 75DD0406 Class II 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, LLC
Devices 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. Lot: 75FD0417 Class II 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, LLC
Food 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. Unit Code: BEST BY JUL 21 2016 4CF22:37:05 to BEST BY  ...
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Class I 4C Foods Corp. has recalled 4C HomeStyle Parmesan Grated Cheese due to Salmonella contamination. 4 C Foods, Corp.
Devices 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. Model numbers: 10281013, 10281163. Class II 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. Siemens Medical Solutions USA, Inc
Food 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 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food 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 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food 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 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food Supreme Choice brand Claw , 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food Supreme Choice brand Special, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food Supreme Choice brand Backfin, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food 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 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food 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 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food Supreme Choice brand Colossal, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Food 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 ALL Class II Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. Supreme Distributors, Inc.
Devices 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. Lot Number: 14BMLB012 Class II Product was held at temperature above the labeled recommended storage temperature Fresenius Medical Care Holdings, Inc.
Drugs 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. NDC #47781-0230-01; Lot # 453289; Exp 08/31/15 Class II 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. Alvogen, Inc
Drugs 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 Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015 Class II Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point. Hospira Inc.
Food Chinese Style Noodles, 10lbs./bx No lot codes, no expiration dates Class II Phoenix Produce is recalling Chinese Style Noodles because it contains undeclared FD&C Yellow No. 5, Yellow No. 6, and Red No. 40. Phoenix Produce & Noodle Company, LLC.
Food 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 Class II 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. JP Trading and Global Imports LLC
Drugs 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 Lot # KM4951; Exp. 04/15 Class III Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. Apotex Corp.
Devices 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 Class II 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. Synthes, Inc.
Devices 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 The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US. These 15 units will receive serial numbers after the software upgrade is installed. THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US: 040-1548-00, 1367-000033, 1369-001517,  ...
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Class II 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). Spacelabs Healthcare Inc
Food 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 Class II Gluten Protein detected up to 50 ppm in product with gluten free statement. Blue Diamond Growers
Drugs 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 100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015 Class III Subpotent; 6 month stability time point Qualitest Pharmaceuticals
Biologics Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Recombinant Vaccine J007354; Class II GARDASIL, one lot with the potential for small glass particles to be present in the vial, was distributed. Merck Sharpe & Dohme Corp
Drugs 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. Lot # 71165; Exp. 12/14 Class II 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. Noven Pharmaceuticals, Inc.
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