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U.S. Department of Health and Human Services

Enforcement Report - Week of July 23, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by: Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658 The product was shipped in cases each of which included 4 paperboard cartons. Each paper board carton held 12-4 oz pouches. 27 LOTE-05-2014 or 22 LOTE-05-2014 Class II Lab analysis detected the pH to be greater than 4.4 Industrias Alimenticias Kern's y Cia. S.C.A.
Veterinary The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments. List Number: 12570; Serial Numbers: 13735001 , 13735002  ...
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Class II There is the potential for the door roller assembly on the Plum XL family of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door toller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Veterinary The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. List Number: 60529; Serial Numbers: 14315003 , 14315004  ...
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Class II Certain Plum A+ fluid shield diaphragms may be out of specification and may cause N250 "Door Open while pumping" or N100 "Unrecognizable Cassette" alarms. Both the N250 and N100 alarm conditions trigger an audible and visual warning to the user, which may occur during setup, infusion or Performance Verification Testing (PVT). If an N250 or N100 alarm is triggered, a delay or interruption in therapy may result. Hospira Inc.
Veterinary The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. List Number: 60529; Serial Numbers: 14315003 , 14315004  ...
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Class II There is a potential for the Plum A+ fluid shield to inadequately prevent fluid from entering into the Plum A+ device (fluid ingress) and potentially causing damage to the pumping mechanism, and/or sensors. Fluid ingress could result in the device being unable to recognize installed cassettes, cause Valve Cassette Test Failures, or result in one or more of the following error codes being displayed: E/N180, E/N181, E/N186, E/N187, E/N250, E/N251, and E346 and cause the devices set up to be interrupted or infusion to stop. Hospira Inc.
Devices SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. Serial numbers 111018DE001 through 140210DE020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers. Class II During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Stryker Communications
Devices SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. Serial numbers 111018DF001 through 120409DF045 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers. Class II During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Stryker Communications
Devices SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. Serial numbers 111108DD001 through 131115DD020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers. Class II During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Stryker Communications
Devices BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. Serial numbers 080924DC001 through 120227DC025 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers. Class II During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Stryker Communications
Devices BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. Serial numbers 080909DB001 through 131021DB015 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers. Class II During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Stryker Communications
Food There are 2 different labels for this same product with the same UPC. Label #1 Individual Bars: 100% natural Zing Complete Nutrition, DARK CHOCOLATE HAZELNUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 Display Carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, DARK CHOCOLATE HAZELNUT, 100% natural, 12/1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g) Label #2 Individual Bars: 100% natural Zing Nutrition Bar, DARK CHOCOLATE HAZELNUT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ. (50g). Label #2 Display Carton: "100% natural Zing Nutrition Bar, Gluten Free, Vegan & Non GMO, DARK CHOCOLATE HAZELNUT, 12/1.76 oz (50g) Bars, NET WT 1 LB 5.12 OZ (600g) Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. Bar UPC code: 8-55531-00216-6; Display Carton UPC code: 8-55531-00217-3; Master Case UPC code: 1-08-55531-00217-0. Best Before: 14 FEB 2014; 21 FEB 2014; 30 MARCH 2014; 13 JUNE 2014; 31 JULY 2014; 23 AUG 2014; 23 SEPT 2014; and 29 OCT 2014. Class II Undeclared milk found in bars labeled "dairy free" or "vegan." NW Nutritional Foods LLC
Food There are two different labels for this product same UPC codes. Version #1 individual bars: 100% natural Zing Complete Nutrition, CHOCOLATE COCONUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g). Version # 1 display carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, Zing Nutrition Bar, 100% natural CHOCOLATE COCONUT, 12/176 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g), Gluten, Soy & Dairy Free. Version # 2 individual bars: 100% Natural Zing Nutrition Bar, DARK CHOCOLATE COCONUT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ, Manufactured For: Zing Bars Seattle, WA 98125. Version # 2 display carton: 100% Natural Zing Nutrition Bar, Gluten Free, Vegan & Non GMO, DARK CHOCOLATE COCONUT, NET WT. 1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g), Manufactured For: Zing Bars Seattle, WA 98125. Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. UPC code for Bar: 8-55531-00205-0; UPC code for Display Box: 8-55531-00212-8; UPC code for Master Case: 1-08-55531-00212-5. Best Before: 14 FEB 2014; 30 MARCH 2014; 13 JUNE 2014; 31 JULY 2104; 23 AUG 2014; 23 SEPT 2014; 29 OCT 2014 and 3 DEC 2014. Class II Undeclared milk found in bars labeled "dairy free" or "vegan." NW Nutritional Foods LLC
Food There are three different labels for this product. Label #1 individual bar 100% Natural Zing Nutrition Bar, DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 display Carton 100% Natural Zing Nutrition Bar, Gluten Free & Vegan, DARK CHOCOLATE SUNFLOWER MINT, 12/1.76 OZ(50g) Bars, NET WT. 1 LB 5.12 OZ. (600g). Label #2 individual bar 100% Natural Zing Nutrition Bar, NUT FREE DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #3 individual bar 100% Natural Zing Nutrition Bar, NUT FREE DARK CHOCOLATE MINT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. Bar UPC code: 8 55531 00206 7; Display Box UPC code: 8 55531 00213 5; Master Case UPC code: 1 08 55531 00213 2. Best Before: 30 MARCH 2014; 13 JUNE 2014; 31 JULY 2104; 23 AUG 2014; 23 SEPT 2014; 29 OCT 2014 and 3 DEC 2014. Class II Undeclared milk found in bars labeled "dairy free" or "vegan." NW Nutritional Foods LLC
Food Individual Bars: 100% Natural Zing Nutrition Bar, CASHEW CRANBERRY ORANGE, Gluten, Dairy & GMO Free, NET WT. 1.76 OZ (50g), Manufactured For: Zing Bars Seattle, WA 98125. Display Carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, 100% natural CASHEW CRANBERRY ORANGE, 12/1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OX (600g). Nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. Bar UPC code: 8-55531-00203-6; Display Carton UPC code: 8-55531-00210-4; Master Case UPC code: 1-08-55531-00210-1. Best Before: 19 SEPT 2014 Class II Undeclared milk found in bars labeled "dairy free" or "vegan." NW Nutritional Foods LLC
Food Just Great Stuff Chocolate Dream Greens, 42 g bar, The bars are individually wrapped and packed in a display containing 12 bars. The displays are shrink wrapped. Produced: 6/1/2013 Code Date: BB 1JUN14 Produced: 6/15/2013 Code Date: BB 15JUN14 Produced: 8/13/2013 Code Date: BB 13AUG14 F1 2253 Produced: 10/24/2014 Code Date: BB 24OCT14 F2 2973 Produced: 12/31/2013 Code Date: BB31DEC14 F4 3653 Produced: 2/20/2014 Code Date: BB20FEB15 F2 0514 Best By date/F1 thru F4 represents the machine the product was wrapped on  ...
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Class II Undeclared milk which was a contaminant of the dark chocolate ingredient. Betty Lou's, Inc.
Devices Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures. Lot No. RA07, Lot No. QP02 Class II During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. Terumo Cardiovascular Systems Corporation
Devices Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures. Lot No. RC07, QM03, QN07, and RA09. Class II During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. Terumo Cardiovascular Systems Corporation
Devices Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures. Pack Lot Nos. RA27T, RA20, RA06T, QP09A, QN18A, RA06A, QP16A, RA20A, RC03A, and RC17T. QM21, RA27, RA27R, QN07, QM28, QF13A, QM21, QN25, QP16, QM14, QN18, QN11, QN04, RA13, QF06R, RC10, QM14T, QM21A, RC24, QF06, QP09, QF20A, QF13R, QF06RT, QG03RA, QG17, QL03, QM14T, QN25A, QE29, QE29T, QL16, QM28A, QM28C, QM28T, QK05,  ...
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Class II During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. Terumo Cardiovascular Systems Corporation
Food Certified Organic, Owl Canyon Whole Eggs, packed in one dozen and half-dozen cardstock packages, with a packing date of 93, 94, 97, or 98. Expiration date of 5/18/14, 5/19/14, 5/22/14, or 5/23/14; location code of 1 or 3 Class I Eggs have the potential to be contaminated with Salmonella Enteritidis Six Dog, LLC
Biologics Red Blood Cells Leukocytes Reduced W117014372289 Class III Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Plasma Frozen W117014372289 Class III Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Platelets Pheresis Leukocytes Reduced W041914003163D; W041914007490U Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W041914003163D; W041914007490U Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W041214008850U Class II Platelets, with a low platelet count, were distributed. Blood Systems, Inc
Biologics Whole Blood W036914204019; W036914203649; W036914203652; W036914400826; W036914204033; W036914203102; W036914300433; W036914203747; W036914203765; W036914203653; W036914203353; W036914900835; Class III Whole Blood, collected in misbranded collection sets, were distributed. Blood Bank Of Delmarva, Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W115912046083; W115912020691; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Plasma Frozen within 24 hours (FP24) W115912046083; W115912042988; W115912020691; W115911027043; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Cryoprecipitated AHF W115912047510; 3429940; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Fresh Frozen Plasma W115913040228; 3527550; 3679362; 3651875; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115913040228; W115912047510; W115912042988; W115911027043; 3429940; 3527550; 3811696; 3679362; 3651875; 3639252; 3634924; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Blood and Blood Products for Reprocessing W115912047510; 3429940; 3811696; 3639252; 3634924; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W045214000785 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Bend Medical Foundation, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W045214000785 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Bend Medical Foundation, Inc.
Devices Siemens RAPIDComm® Data Management System. The RAPIDComm® Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network, Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194 Class III RAPIDComm® 5.0 Screen Layout will display incorrect test names Siemens Healthcare Diagnostics Inc
Veterinary VetOne Vetrimycin 100, Oxytetracycline Hydrochloride Injection, 100 mg/mL Sterile, 500 mL, ANDA 200-452, Distributed by: MWI, Meridian, ID. Made in UK Lot 3431-91; exp 10/31/2016 Class III The product appears cloudy when it should be a clear amber solution. Norbrook Inc
Veterinary Terra-Vet 100, Oxytetracycline Hydrochloride Injection, 100 mg/mL, Multiple Dose Sterile Vial, 500 mL, ANDA 200-452, Veterinary Resources, LTD. Manufactured for: Aspen Veterinary Resources, Ltd., Liberty, MO. Lot 3431-91; exp 10/31/2016 Class III The product appears cloudy or milky when it should be a clear amber solution. Norbrook Inc
Devices Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer. material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272 Class II An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DICOM data failed because the loaded CD was not recognized by the system. Siemens Medical Solutions USA, Inc
Biologics Platelets Pheresis Leukocytes Reduced W333514007688 Class II Blood product, which did not meet the acceptable product specifications for release, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Plasma Frozen W040713435414 Class III Blood products, collected from a donor with an invalid result for body temperature, were distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W040713138655; W040713435414; W040713461246 Class III Blood products, collected from a donor with an invalid result for body temperature, were distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W140913328204 Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. South Texas Blood & Tissue Center
Biologics Platelets Irradiated W140913328204 Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. South Texas Blood & Tissue Center
Biologics Red Blood Cells Leukocytes Reduced W051513131786 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Innovative Blood Resources
Biologics Blood and Blood Products for Reprocessing W051513131786 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W140914119101 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. South Texas Blood & Tissue Center
Biologics Platelets Irradiated W140914119101 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. South Texas Blood & Tissue Center
Food Mt. Olive, PepperPAK Jalapeno Slices, 4-3.7fl oz cups, Net fl oz 14.8 (438 ml), Mt Olive Pickled Co., Inc., Corner of Cucumber and Vine, P.O. Box 609, Mt. Olive, NC 28365-0609. Case UPC = 0930010016 Jalapeno PepperPak code date 1FI1114A and 1FI1114B; Sleeve UPC = 0930010015 Hamburger Dill Chips code date 1FI1114A and 1FI1114B Class III Undeclared Non-Allergen: Sulfites. Mt. Olive Pickle Company Inc
Devices BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli. Lot. Number - 3224281 / Exp. Date - 2014/06/09 , Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09 Class III A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct. Becton Dickinson & Co.
Biologics Olerup SSP® HLA Typing Kits The kit contains dried primer solutions are pre-aliquoted into cut PCR trays with 0.2 ml wells. These trays, one for each test, are packaged in inner boxes of paper and then together with mastermix vials in outer paper boxes. The kits are available in two formats, kits containing PCR Master Mix including Taq polymerase respective kits containing PCR Master Mix without Taq polymerase. Olerup SSP® HLA Typing Kits ALow: Lot 44V, exp. September 1, 2015; ALow Screening: Lot 28V, exp. July 1, 2016; A-B-C: Lots 64S, exp. March 1, 2016, and 63V, exp. September 1, 2016; A-B-DR: Lot 63S, exp. March 1, 2016; A-B-DR-DQ: Lot 70S, exp. March 1, 2016 Class II HLA typing assay, associated with false negative results, were distributed. Olerup SSP AB
Devices Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration. lot # H13136, exp. August 2014. Class II One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use. Axcentria Pharmaceuticals, LLC
Drugs Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015 Class II Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number Axcentria Pharmaceuticals, LLC
Food Plank Road Round (Pasteurized Cows Milk Cheese), 4 ounce plastic cups are sealed with a protective band. Lot # 922 - Plank Road Round, Production Date : 04/16/14 Class II Failure to achieve proper pasteurization due to one or more of the following critical factors: Improper Air space temperature, Pasteurization time, and/or Milk Temperature. Caromont Farm
Food Chevre (Pasteurized Goats Milk Cheese) .-Four oz. cups Fresh Chevre / Bulk Chevre - One, two, and five pound sizes Lot # 937 - Chevre, Production Date : 05/12/14 Class II Failure to achieve proper pasteurization due to one or more of the following critical factors: Improper Air space temperature, Pasteurization time, and/or Milk Temperature. Caromont Farm
Biologics Bone THB0108643; THB0108617; THB0108648; THB0108661; THB0108794 Class III Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Innovasis, Inc
Biologics Bone 0098360048; 0098360049; 0098360050 Class III Human bone allografts, mislabeled with an incorrect expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Veterinary Huvepharma Amprol 25% (amprolium), Type A medicated article, NADA 012-650, Manufactured by: Huvepharma, Inc., St. Louis, MO, Distributed by: Huvepharma, Inc., Peachtree City, GA. Lot # HSC119; expiration date: February 2017 Class II The product may contain broken glass. Huvepharma Inc
Food Echinacea Agustifolia Root PE 4:1 The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg. EC330955, Lot #C133/068/A13 Class III Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507. Naturex Inc.
Food Echinacea Agustifolia PE 4& echinosides The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg. ED161322, Lot #C129/081/A13 Class III Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507. Naturex Inc.
Food Echinacea Angustifolia Root PE 4: The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg. EC330955, Lot#C073/050/A14 Class III Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507. Naturex Inc.
Food Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ. (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055 No codes or dates Class II Mango Enchilado contains undeclared colors and sulfites. It is also contaminated with lead. Oaxaca Mexican Products
Veterinary Surpass (1% diclofenac sodium) Topical Anti-Inflammatory Cream, 124 g tube, UPC 012313449810, NADA 141-186. Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO. Lot # 130502, expiration date 05/2015 Class III During stability testing, the product was found out of specification. Boehringer Ingelheim Vetmedica Inc
Food Wegmans Cinnamon Raisin Buns, NET WT. 12 OZ (340g), UPC 77890 92218 ---Baked by Wegmans Food Markets Inc. - Rochester, NY 14603 BEST IF USED BY 6/19 TU (stamped on top of package) Class I The Raisin Cinnamon Buns contain undeclared eggs which may also be raw. This poses a potential health risk to consumers if the product is consumed. Wegmans Food Markets, Inc.
Food Schnucks Bakery 8" Devil's Food Cake, net wt. 2 lb 13 oz, UPC: 04131831186. Also packaged as Schnucks Bakery Half Devil's Food Cake, net wt. 1 lb 7 oz plastic, UPC: 04131831078 Schnuck Markets, Inc., St. Louis, MO. 8" Devil's Food Cake: Item: 31-40080; Half Devil's Food Cake: Item: 31-40503. Class II The product contains pecan pieces as a top garnish and the product label does not include pecan or tree nuts. Schnucks Markets Inc
Biologics Cornea 1405303ODC; 1405303OSC Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Donor Network of Arizona
Devices SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue Lot Numbers: 50476555, 50481446 Class II Sterility of device is compromised due to breach in sterile barrier Smith & Nephew, Inc. Endoscopy Division
Devices SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue Lot Numbers: 50477397, 50481448 Class II Sterility of device is compromised due to breach in sterile barrier Smith & Nephew, Inc. Endoscopy Division
Devices SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899 Class II Sterility of device is compromised due to breach in sterile barrier Smith & Nephew, Inc. Endoscopy Division
Devices SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue Lot Numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, 50485589 Class II Sterility of device is compromised due to breach in sterile barrier Smith & Nephew, Inc. Endoscopy Division
Devices SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684 Class II Sterility of device is compromised due to breach in sterile barrier Smith & Nephew, Inc. Endoscopy Division
Drugs ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. Lot #: 71132, Expiry: 02/2017 Class II Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. CareFusion 213, LLC
Devices Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products P/N Lynx TM20-4H-01: T41202012, T41202013, T41203001, T41203002, T41203003, T41203010, T41204001 to T41204006 P/N Lynx TM20-4H-03 distributed to end user accounts with serial number T41204001 P/N Lynx TM20-2H-03 distributed to Medidenta private labeled as "Meditorque I 20  ...
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Class II MTI Precision Products LLC received a complaint regarding a sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. MTI Precision Products LLC.
Food CTF Brand Tapioca Pearl Net Wt: 14 oz. (400G.) Exporter: Combine Thai Foods Co., Ltd. 359/716-17 Spot Chalaem Nimit, Chalaem Nimit Rd. (Pradu 1) Bangkro, Bangkholaem, Bangkok 10120 Thailand Product of Thailand UPC 8851381560506 no codes Class II Tapioca pearl contains unapproved and undeclared colors. New B.C.N. Trading Inc
Devices Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513 Class II There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another. Excelsior Medical Corp
Food Vita Classic Premium Sliced Smoked Atlantic Nova Salmon, packaged in a black vacuum-sealed, plastic film package for retail sale. Product is labeled "ready to serve" and each package contains 4 ounces of product. UPC: Case (12/4oz. packages), 10022635700381 *** Package (4 oz), 22635 70038 ****** ITEM NO: 140490 ****** SELL BY AUG 17 2014 ****** LOT: 00764B Class I This voluntary recall is being initiated due to a positive Listeria monocytogenes sample taken by the Florida Department of Agriculture and Consumer Services. Vita Food Products, Inc.
Devices ACL TOP (Base), automated coagulation laboratory instrument. Start SN and Date: 03110101 Nov 2003 and End SN and Date 11111174 Nov 2011 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices ACL TOP 700, automated coagulation laboratory instrument. Start SN and Date: 09080100 Aug 2009 and End SN and Date 14050732 May 2014 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices ACL TOP CTS, automated coagulation laboratory instrument. Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices ACL TOP 700 LAS, automated coagulation laboratory instrument. Start SN and Date: 08120100 Dec 2008 End SN and Date 14050198 May 2014 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices ACL TOP 500 CTS, automated coagulation laboratory instrument. Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices ACL TOP 700 CTS, automated coagulation laboratory instrument. Start SN and Date: 09120101 Dec 2009 End SN and Date 14050368 May 2014 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices ACL TOP 300 CTS, automated coagulation laboratory instrument. Start SN and Date: 11110101 Nov 2011End SN and Date 14051302 May 2014 Class II Potential for sample misidentification. Instrumentation Laboratory Co.
Devices Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment. DPIs with Lot Number 1405006 and higher. Class II Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. Shape Medical Systems, Inc
Devices V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02. Class II Several issues with the V-Series Monitoring System 12-lead ECG interpretation feature. These issues impact the 12-lead ECG feature only; standard 12-lead ECG monitoring is not affected. (1) The 12-lead Standard and Extended Measurement Report will include false measurements when the P wave or QRS axis cannot be accurately determined by the algorithm. (2) The Median Complex and Extended Measurement Report will display the representative beat as 25% larger than actual signal input. (3) When a patient date of birth is imported into the V Series from an external source, such as Mindray's Gateway, e-Gateway, Panorama Central Station or Panorama Workstation, the age will not pass into the 12-lead ECG interpretation algorithm. The algorithm analysis will use the default adult criteria of "50 year adult" in which case the interpretive statements may be incorrect, depending on the actual age of the patient. Note: when the patients date of birth is manually entered into the V-Series the correct age is accepted and the appropriate interpretation algorithm is applied. Mindray DS USA, Inc. dba Mindray North America
Devices Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS. Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10 Class II Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae. Remel Inc
Devices Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018. Class II Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial. Zimmer, Inc.
Devices Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. GD895771 Class II Inadequate iodine and packaging related defects. Baxter Healthcare Corp.
Devices Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600 Class II The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. Siemens Healthcare Diagnostics Inc.
Devices Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability. Lot # 2239818, Model - Titan-T 5K Motor, Catalog Number - 263940, with serial numbers: AC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7 Class II The housing of 5K motor was laser marked incorrectly as a 20K motor. Dental EZ Group Star Dental Division
Drugs Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 Lot 3805324A Exp. 11/14 Class III Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Aprif tablets due to out of specification impurity test results. Teva Pharmaceuticals USA
Drugs Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58 Lot 33805507A, Exp. date 11/14 Class III Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Mircette tablets due to out of specification impurity test results. Teva Pharmaceuticals USA
Drugs Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58 Lot 33805325A, Exp.11/14 Class III Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Kariva tablets due to out of specification impurity test results. Teva Pharmaceuticals USA
Drugs Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 Lot 33805449A, Exp. 12/14 Class III Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Velivet distributed by Barr Laboratories, Inc. due to out of specification impurity test results. Teva Pharmaceuticals USA
Devices Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209 Class II With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. Spacelabs Healthcare Inc
Food Walnut Creek Farmers Cheese- 6lbs in plastic bags- 4 per case PLU: 4030 Lot 06111 Class II Milk used in the products tested positive for antibiotics. Pearl Valley Cheese Inc
Food Walnut Creek Marble Cheese-- 6lbs of cheese in plastic bags; 4 per case PLU: 6030 Lot: 06112 Class II Milk used in the products tested positive for antibiotics Pearl Valley Cheese Inc
Food Whey Protein Concentrate -- No labeling sold in bulk tanker None - ship date: 06/12/13 Load # 36866 Class II Milk used in the products tested positive for antibiotics Pearl Valley Cheese Inc
Food Cream; Sold in bulk; No labeling None- Ship date 6/13/2014 Class II Milk used in the products tested positive for antibiotics Pearl Valley Cheese Inc
Devices Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration. Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018 Class II Lack of Sterility Assurance PIONEER SURGICAL TECHNOLOGY, INC.
Food Velveeta Original Pasteurized Ripe Cheese Product sold under the Kraft brand and individually wrapped in plastic and sold in a card stock carton with a net weight of 2 lb. (32 oz.). Consumer Package Code: 17 DEC 2014 09:34 - 13:35 Class II Kraft Foods is recalling part of one sku of Velveeta Original Pasteurized Recipe Cheese Product because a preservative ingredient was found to be present at levels below specification. Kraft Foods Group
Devices e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device. 9073 ; 11779 ; 9180 ; 9293 ; 11527 ; 10074 ; 9046 ; 9027 ; 9033 ; 9155 ; 9206 ; 10195 ; 10129 ; 10302 ; 10083 ; 10304 ; 10219 ; 11096 ; 11211 ; 11176 ; 11723 ; 11729 ; 11791 ; 10017 ; 10336 ; 9126 ; 9252 ; 9276 ; 10054 ; 11076 ; 11252 ; 11372 ; 11371 ; 11476 ; 11478 ; 11498 ; 9152 ; 11710 ; 10314 ; 9090 ; 9037 ; 9169 ; 9190 ; 10030 ; 10301 ; 9189 ; 9083 ; 9116 ; 9150 ; 9104 ; 9273 ; 9281 ; 9200 ; 9172 ; 9149 ; 9292 ; 9249 ; 9239 ; 9310 ; 9294 ; 10018 ; 10046 ; 11250 ; 10220 ; 10232 ; 10279 ; 11012 ; 11063 ; 11029 ; 11069 ; 11535 ; 11536 ; 11169 ; 11350 ; 11231 ; 11316 ; 11555 ; 11566 ; 11341 ; 11342 ; 11419 ; 11682 ; 11683 ; 11460 ; 11473 ; 11516 ; 9185 ; 11748 ; 9203 ; 11431 ; 11587 ; 10229 ; 11692 ; 11693 ; 11595 ; 9001 ; 9089 ; 9110 ; 9008 ; 9052 ; 9137 ; 9025 ; 9098 ; 9163 ; 9023 ; 9147 ; 9198 ; 10029 ; 10185 ; 11078 ; 11079 ; 10361 ; 11228 ; 11054 ; 11093 ; 11092 ; 11178 ; 11134 ; 11227 ; 11210 ; 11326 ; 11517 ; 10052 ; 11105 ; 9197 ; 10173 ; 10221 ; 10305 ; 10355 ; 11339 ; 11518 ; 11625 ; 11746 ; 11783 ; 9061 ; 9130 ; 10073 ; 10050 ; 11042 ; 11137 ; 11266 ; 11571 ; 11462 ; 11402 ; 11501 ; 11511 ; 11630 ; 11711 ; 11741 ; 10327 ; 11520 ; 11375 ; 11500 ; 11650 ; 10136 ; 9016 ; 9156 ; 9148 ; 10048 ; 10126 ; 11098 ; 11253 ; 11532 ; 11513 ; 9194 ; 10002 ; 9019 ; 9080 ; 9232 ; 9268 ; 10023 ; 10349 ; 10347 ; 11101 ; 11638 ; 11641 ; 11335 ; 9144 ; 11015 ; 11022 ; 11567 ; 11570 ; 11598 ; 9067 ; 9031 ; 9029 ; 11087 ; 9118 ; 9071 ; 9248 ; 9124 ; 10024 ; 10179 ; 10159 ; 10243 ; 11038 ; 11081 ; 11401 ; 11312 ; 11422 ; 11303 ; 11299 ; 11320 ; 11465 ; 11503 ; 11523 ; 11505 ; 11631 ; 11019 ; 11158 ; 9041 ; 9069 ; 10339 ; 10340 ; 9259 ; 10070 ; 11380 ; 10231 ; 11198 ; 9035 ; 10094 ; 10039 ; 10208 ; 10230 ; 10222 ; 11225 ; 11256 ; 11287 ; 11484 ; 11486 ; 11529 ; 11554 ; 11654 ; 11123 ; 9087 ; 9300 ; 11292 ; 11603 ; 11541 ; 11021 ; 9217 ; 9048 ; 9004 ; 9238 ; 9234 ; 10067 ; 10032 ; 10040 ; 10012 ; 10053 ; 10184 ; 10282 ; 11229 ; 11237 ; 11236 ; 11434 ; 11466 ; 10181 ; 11135 ; 11645 ; 9049 ; 10008 ; 10078 ; 9307 ; 9231 ; 9311 ; 10092 ; 10141 ; 10187 ; 11049 ; 11275 ; 11738 ; 10110 ; 9162 ; 11072 ; 11142 ; 11263 ; 9188 ; 9135 ; 9070 ; 9021 ; 9081 ; 9250 ; 10071 ; 10321 ; 11033 ; 11060 ; 11116 ; 11165 ; 11175 ; 11212 ; 11214 ; 11267 ; 11323 ; 11751 ; 11760 ; 9254 ; 10057 ; 10324 ; 11164 ; 11483 ; 11528 ; 11593 ; 11655 ; 10010 ; 5517 ; 10150 ; 10117 ; 11055 ; 10313 ; 11133 ; 9040 ; 9003 ; 9100 ; 10160 ; 9256 ; 10013 ; 10109 ; 10069 ; 10075 ; 10273 ; 11309 ; 11053 ; 11124 ; 11399 ; 11221 ; 11224 ; 11334 ; 11314 ; 11338 ; 11358 ; 11307 ; 11437 ; 11521 ; 11543 ; 11608 ; 10254 ; 9291 ; 10101 ; 9036 ; 9057 ; 9010 ; 10049 ; 10061 ; 9138 ; 9097 ; 9228 ; 9007 ; 9237 ; 9113 ; 9115 ; 9255 ; 10022 ; 10100 ; 10108 ; 10113 ; 10121 ; 10133 ; 10188 ; 10277 ; 10255 ; 11052 ; 10270 ; 10362 ; 10284 ; 11006 ; 11070 ; 11083 ; 11071 ; 11088 ; 11230 ; 11260 ; 11282 ; 11440 ; 11387 ; 11359 ; 11504 ; 11612 ; 11626 ; 11661 ; 11627 ; 11694 ; 11714 ; 11764 ; 11728 ; 11445 ; 11268 ; 10025 ; 10224 ; 10225 ; 10342 ; 11074 ; 11062 ; 11435 ; 9128 ; 9295 ; 11537 ; 9142 ; 11792 ; 9125 ; 9123 ; 9015 ; 9058 ; 9212 ; 9022 ; 9092 ; 9134 ; 9245 ; 10197 ; 9192 ; 9214 ; 9170 ; 9187 ; 10006 ; 10009 ; 9270 ; 10000 ; 10163 ; 10065 ; 10303 ; 10296 ; 10241 ; 11051 ; 11143 ; 11182 ; 11089 ; 10294 ; 11243 ; 11202 ; 11255 ; 11300 ; 11294 ; 11382 ; 11325 ; 11441 ; 11471 ; 11427 ; 11546 ; 11468 ; 11544 ; 11550 ; 11614 ; 11679 ; 11701 ; 11759 ; 11009 ; 11698 ; 9199 ; 11418 ; 9082 ; 10062 ; 10119 ; 10209 ; 11073 ; 11163 ; 11522 ; 11559 ; 11585 ; 9 Class II Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose. Siemens Medical Solutions USA, Inc.
Devices Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device. 1) Symbia E Dual Head System; Model Number: 10275879  ...
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Class II Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose. Siemens Medical Solutions USA, Inc.
Drugs VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70 Lot H45241, exp. 11/16 Class III Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. Pfizer Inc.
Drugs POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16. Lot #: 04413, Expiry: 02/15 Class III Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". Poly Pharmaceuticals, Inc
Drugs LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16. Lot #: 03613, Expiry: 02/15 Class III Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". Poly Pharmaceuticals, Inc
Devices LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology E14128 & E14129 Class II Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'. Laser Peripherals LLC
Food Häagen-Dazs Chocolate Chocolate Chip Ice Cream, 14 oz, UPC of 74570-08400 BATCH CODE: 4133580418D/ Best By 13 May 2015 Batch Code date Breakdown:YDDDPPPPLLO Y-Year (2014) JJJ-Julian date (133) PPPP-Plant code (5804) Line (14) O- D-Shift Class I Nestle is recalling the Häagen-Dazs Chocolate Chocolate Chip Ice Cream because it mislabeled and the ingredient statement does not identify peanuts. The affected products are labeled as Häagen-Dazs Chocolate Chocolate Chip Ice Cream, and lid labeled as Häagen-Dazs Chocolate Peanut Butter. These mismatched packages contain Chocolate Peanut Butter ice cream, and the ingredient statement on the carton applies to Chocolate Chocolate Chip Ice Cream and does not identify peanuts. Nestle
Drugs Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60. Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015. Class III Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Fougera Pharmaceuticals Inc.
Drugs Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60. Lot: 849R, Exp 04/2015 Class III Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Fougera Pharmaceuticals Inc.
Devices Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L Catog No. 110-4B, Lot No.: 305000222640, 305000223280, 305000223866, 305000223867, 305000224353, 305000225045, 305000225632, 305000225633, 305000226127, 305000226836, 305000226844, 305000227128, 305000228521, 305000228522, 305000228971, 305000229328, 305000229329, 305000229825, 305000229826, 305000230302, 305000230303, 305000230780, 305000230781, 305000231461, 305000231462, 305000232098, 305000232099, 305000232604, 305000232605, 305000233240, 305000233241, 305000233242, 305000233243, 305000233607, 305000233608, 305000234304, 305000235022, 305000236104, 305000236105, 305000236653, 305000236655, 305000237232, 305000238263, 305000238818, 305000238819,  ...
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Class II Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment. Integra LifeSciences Corp.
Drugs Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61. Lot #: 39474DK, Expiry: 03/01/2016. Class II Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Hospira Inc.
Devices Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. E2S47525 Lot 1301 and E2S47535 Lot 1301 Class II Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. Innovasis, Inc
Drugs Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08. Lot #: 3045659, 3048256, Exp 07/14 Class III Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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