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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Product is SoftBank software (versions 21.4.2 to 23.0.0). SoftBank Version 21.4.2 with 3.1.2 ASCII base; SoftBank Version 21.4.3 with 3.1.3 ASCII base; SoftBank Version 21.4.3 with 3.1.4 ASCII base; SoftBank Version 21.4.4 with 3.1.4 ASCII base; SoftBank Version 22.4.0 with 3.1.3 ASCII base; SoftBank Version 22.4.1 with 3.1.4 ASCII base; SoftBank Version 23.0.0 with 3.1.4 ASCII base; SoftBank Version 23.0.0 with 3.2.0 ASCII base; SoftBank Version 23.0.0 with 3.2.3 ASCII base; SoftBank Version 23.0.0 with 3.2.4 ASCII base Class II Software, with a glitch or defect, was distributed. SCC Soft Computer
Biologics Red Blood Cells 1280475 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced 1295730 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Community Blood Center
Biologics Red Blood Cells 4198405, 4200938 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Community Blood Center
Biologics Red Blood Cells 3549179, 3547437 Class II Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced 9038318 Class II Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center
Biologics Recovered Plasma 9038318, 3547437 Class II Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center
Biologics Platelets Pheresis Leukocytes Reduced 6054316 Class II Blood product, with a low platelet count, was distributed. Community Blood Center
Biologics Platelets Pheresis Leukocytes Reduced 6054666 Class II Blood product, with a low platelet count, was distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced 11GW59870, 11GW59871, 11GW59874, 11GW59876 Class III Blood products, tested using the Hematastat equipment that was missing the daily quality control records, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02LC59689 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American Red Cross Blood Services
Biologics Source Plasma 330060575, 330060732, 330061380, 330061712 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced 02LJ48701 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. American Red Cross Blood Services
Biologics Recovered Plasma 02LJ48701 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. American Red Cross Blood Services
Biologics Source Plasma 4040029292, 4040029296, 4040029301, 4040029294, 4040029304, 4040029297, 4040029289, 4040029298, 4040029299, 4040029305, 4040035505, 4040035512, 4040035517, 4040035522, 4040035523, 4040030105, 4040029306, 4040030109, 4040030111, 4040030114, 4040030115, 4040030116, 4040030117, 4040030118, 4040030225, 4040030228, 4040030232, 4040030302, 4040030306, 4040030308, 4040030309, 4040030310, 4040030311, 4040030312, 4040030313, 4040030314, 4040030315, 4040030316, 4040030317, 4040030318, 4040030319, 4040030320 Class III Blood products, which may have reached unacceptable temperatures during storage, were distributed. CSL Plasma
Biologics Source Plasma 4210087445, 4210086539, 4210085985, 4210084967, 4210084427, 4210083400, 4210082857, 4210081860, 4210081310, 4210080472, 4210080007, 4210078342, 4210077910, 4210076935, 4210076450, 4210075537, 4210075213, 4210074270, 4210073891, 4210073088, 4210072653, 4210071612, 4210071224, 4210070322, 4210069960, 4210069078, 4210068483, 4210067206, 4210066479, 4210065781, 4210064777, 4210063218, 4210062738, 4210061939, 4210061350, 4210060514, 4210060086, 4210059008, 4210058606, 4210057603, 4210057170, 4210055403, 4210054727, 4210053865, 04210053444 Class II Blood products, collected from a donor who did not have a physical examination, were distributed. CSL Plasma Inc
Biologics Platelets Pooled 0090059 Class III Blood product, for which the quality control testing was incomplete, was distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 06BOHA0323 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Bio-Blood Components, Inc.
Biologics Plasma Frozen 50LW55055 Class III Blood products, manufactured from a whole blood unit that may have had an extended collection time, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 02LP18662 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02LP18662 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 02P96564, 02P96666, 02P96637, 02P96670, 02P96626, 02P96598, 02P96566, 02LS01159 Class III Blood products, which may have reached an unacceptable temperature during storage, were distributed. American Red Cross Blood Services
Biologics Source Plasma 370060133, 370060924, 370061166, 370061723, 370063443, 370063689, 370064569, 370066763, 370069527, 370071330, 370072723, 370073353 Class III Blood products, collected from a donor who was previously deferred, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 370055602 Class II Blood product, collected from a donor who did not have a complete physical examination, was distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 4100385656, 4100384401, 4100382991, 4100378926, 4100377543, 4100376601, 4100372446, 4100367994, 4100366798, 4100365448, 4100362864, 4100360304, 4100357558, 4100356358, 4100341534, 4100337267, 4100328589, 4100323411, 4100315386, 4100299217, 4100288682, 4100283746, 4100280969 Class II Blood products, collected from a donor who received a piercing within one year of donation, were distributed. Csl Plasma Inc
Biologics Source Plasma 4100390029, 4100388970, 4100388493, 4100387277, 4100386693, 4100384472, 4100382876, 4100381825, 4100380949, 4100379320, 4100378814, 4100377047, 4100376495, 4100374637, 4100374066, 4100372123, 4100371499, 4100367023, 4100366099, 4100364569, 4100363343, 4100361829, 4100360661, 4100359312, 4100357701, 4100356440, 4100355151, 4100354324, 4100352193, 4100351244, 4100349719, 4100348960, 4100347312, 4100346498, 4100344650, 4100343847, 4100342040, 4100341196, 4100339642, 4100338055, 4100337306, 4100335571, 4100334696, 4100332958, 4100332137, 4100330514, 4100329685, 4100328112, 4100327320, 4100325907, 4100323557, 4100322764, 4100321304, 4100320369, 4100319028, 4100317970, 4100316746, 4100315642, 4100313416, 4100311769, 4100310871, 4100309219, 4100307559, 4100306536, 4100304555, 4100303355, 4100302051, 4100301021, 4100298987, 4100297752, 4100296643, 4100295022, 4100294463, 4100292817, 4100291830, 4100290225 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. Csl Plasma Inc
Biologics Source Plasma 4100392051, 4100391500, 4100389118, 4100388452, 4100387385, 4100386645, 4100385652, 4100384768, 4100382850, 4100382474, 4100380926, 4100380407, 4100378762, 4100378159, 4100376439, 4100375784, 4100373987, 4100373333, 4100371396, 4100370969, 4100369129, 4100368322, 4100366367, 4100365648, 4100363580, 4100362777, 4100360899, 4100360181, 4100358258, 4100357376, 4100355646, 4100354819, 4100352727, 4100351938, 4100350267, 4100349445, 4100347445, 4100346605, 4100344801, 4100343970, 4100342162, 4100341325, 4100339782, 4100339283, 4100337032, 4100336269, 4100334446, 4100333691, 4100332065, 4100331442 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Csl Plasma Inc
Devices A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient. B420702032 to 0402110097 Class II Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator . Steris Corporation
Biologics Cornea 110112OS; 110112OD Class II Corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Upstate New York Transplant Services, Inc.
Food Nitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2. The product does not bear any manufacturing codes. All product on the market at the time the recall was initiated on 5/25/2012 is subject to recall. Class I FDA analysis of the product found that the product consisted of mainly sodium nitrite. The product's label failed to bear adequate directions for use as required in 21 CFR 172.175. Failure to provide these directions for use may result in overuse that can pose an life-threatening hazard to health. Hocean Inc
Biologics Plasma Frozen Cryoprecipitated Reduced W117009159701N; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W117010196924W; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Plasma Frozen W117011455152N; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Cryoprecipitated AHF, Pooled W117009159701N; W117010100874Y; W1170114435834; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Blood and Blood Products for Reprocessing W117010196924W; W1170114417093; Class III Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Fresh Frozen Plasma W117009194370I; W117009125131Y; W117011426472Y; W1170101117358; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced W117009159701N; W117009125131Y; W117009194370I; W117011426472Y; W1170101117358; W117011455152N; W1170114417093; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. Blood Centers of the Pacific - Irwin Center
Devices CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep 20182-1006 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep 15011-0904 and 16363-0908 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 15287-0905, 15974-0906, 17052-0910 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 14161-0901 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 20144-1006, 19702-1005 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 14163-0901 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 15924-0906, 16975-0910, 17709-0912 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 19134-1004 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 19850-1006 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Devices BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep 14255-0901 Class I The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications. Custom Medical Specialties, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W0423110455999 Class II Blood products, collected from a donor with a history of malaria, were distributed. Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced W042311056937V; W0423110503973; W042311040445E Class II Blood products, collected from a donor with a history of malaria, were distributed. Blood Systems, Inc
Drugs ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA Antiseptic wipes shipped since July 02, 2009. Lots: JT14509, JT15209, JT20609, JT20909, JT23709, JT27809, JT32809, JT00710, JT15810, JT18310, JT18810, JT23210, JT25810, JT27610, JT31510, JT35610, JT35911, JT04811, JT05311, JT11811, JT15211, JT15911, JT18211, JT18211, JT21511-1, JT26311, JT30711, JT22011-1, JT01012, JT04112, JT06512, JT07512, JT07710, JT14509, JT15209, JT21409, JT20609, JT33009, JT00710, JT18810, JT23210, JT35911, JT05311, JT11811, JT26311, JT01012, JT14509, JT15209, JT20609, JT15209, JT23709, JT27809, JT00710, JT00710, JT18310, JT18810, JT23210, JT23210, JT27610, JT31510, JT05809, JT14509, JT15209, JT21209, JT27809, JT12510, JT15810, JT18310, JT11811, JT13211, JT15911, JT35911, JT01012, JT30711 Class II Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer) Dukal Corp.
Drugs Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031 Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711 Class II Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer) Dukal Corp.
Biologics Fresh Frozen Plasma (Apheresis) W121611912691, W121611907470 Class III Blood products, which were not frozen within six hours of collection, were distributed. The Blood Connection, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W043212033535 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043211081628 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Recovered Plasma W043211081628 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced 1427905 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W050912009497 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050912009497 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Recovered Plasma W050912012863 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced W050912012863, W050912013540 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050912009254 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050912010131 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W050912013552 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced W050912011703, W050912009254 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced 53H10237 Class III Blood product, which was incorrectly labeled as negative for the N red cell antigen, was distributed. Amer. National Red Cross-Greater Chesapeake & Potomac Reg.
Biologics Recovered Plasma 011LQ82629 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Devices JUGGERKNOT IN·GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone. REF. 912064 LOT 121040, 497540, 839530 Class II Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft. Biomet, Inc.
Biologics Recovered Plasma 16GR73221 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross
Biologics Cryoprecipitated AHF, Pooled 16GR73221 (pool ID: 16N54970) Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross
Drugs Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label) lot numbers Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013 rest of world lots being recalled: list M1685A001, lots numbers Y151686AB, exp MAY 2013 and Y131686AA, exp MAR 2013; list M1723A001, lot number Y121686AF, exp SEP 2013; list M1686ADE1, lot numbers Y121686AA, exp SEP 2013 and Y151686AC, exp NOV 2013; list M1686AFR1, lot numbers Y121686AG, exp SEP 2013 and Y131686AB, exp SEP 2013; list M1714A001, lot number Y121686AC, exp SEP 2013; list M1686ANO3, lot number Y121686AE, exp SEP 2013; list M1686ASE2, lot number Y121686AB, exp SEP 2013 Class II The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. Hospira Inc.
Drugs Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46 lot numbers Y131994AA, exp AUG 2013; Y141994AA, exp SEP 2013; Y151994AA, exp SEP 2013; Y161994AA, exp NOV 2013; Y171994AA, exp NOV 2013 and Y181994AA, exp NOV 2013 Class II The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. Hospira Inc.
Drugs Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41 lot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013 Class II The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. Hospira Inc.
Drugs Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50 lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013 Class II The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. Hospira Inc.
Biologics B17 SSP UniTray® Kit, REF 472303 and 472313; B Locus High Res SSP UniTray® Kit , REF 4730010 and 4730110; AllSet Gold SSP HLA-B17 High Res Kit, Prod.no. 541120D, AllSet Gold SSP HLA-B Locus High Res Kit , Prod.no. 54020D. . 472303 (B17 SSP UniTray Kit): 004743203, 004825654, 004904114, 004944916, 0041047204 472313 (B17 SSP UniTray Kit with Taq Polymerase) 004743203794936, 004743203824725, 004743203867126, 004825654862612, 004825654902239, 004825654903448, 004825654908705, 004825654933983 004904114936659, 004904114943927, 004904114989957, 004904114991724 0049449161006545, 0049449161029905, 0049449161036926, 00410472041097465 4730010 (B Locus High Res SSP UniTray Kit) 008709385, 008757730, 008800850, 008839301, 008873000, 009910766, 009984375 0101103786 4730110 (B Locus High Res SSP UniTray Kit with Taq Polymerase) 008709385760267, 008709385764018, 008709385764321, 008709385770871, 008839301892884, 008839301895965, 008839301900752, 008839301903610, 008709385786802, 008709385790179, 008709385791195, 008709385791779, 008709385792235, 008709385794392, 008709385799832, 008757730812167, 008757730825400, 008757730826478, 008757730827309, 008757730832868, 008757730835072, 008800850838882, 008800850842278, 008800850845743, 008800850849098, 008800850853960, 008800850857260, 008 800850 859419 008800850864238, 008800850874250, 008839301884136, 008839301891810, 008839301907862, 008839301923305, 008873000925324, 008873000940462, 008873000942042, 009910766979658, 009910766990558, 0099107661007232, 0099107661013361, 0099107661016456, 0099107661029333, 0099107661032390, 0099107661038471, 0099107661046552, 0099107661048423, 0099107661070124, 0099843751071655, 0099843751077181, 0099843751112028, 0099843751112356, 0099843751113862, 01011037861143513, 01011037861148166 541120D (AllSet Gold SSP HLA-B17 High Res Kit - 10 Tests) 004744187, 004841439, 0041030324 54020D (AllSet Gold SSP HLA-B Locus High Res Kit - 10 Tests) 008707067, 008775767, 008796669, 008839303, 009910772, 009979631 Class II HLA typing assay, associated with false negative results, was distributed. Life Technologies, Inc.
Devices BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention. Catalog number: 335775; Lot number 33412. Class II Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. BD Biosciences, Systems & Reagents
Food Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)***See Bottom Panel for Nutritional Information***" Bottom of tin: "***Nutrition Facts Serving Size 4 Cookies (30g)***INGREDIENTS: Wheat Flour, Sugar, Butter, Eggs, Salt, Soy Lecithin (Emulsifier) Leavening Agent (Sodium bicarbonate), Artificial Flavor.***Contains Egg, Milk, Wheat, Soy***Manufactured in a facility that process peanuts and tree nuts.***Distributed By: ATICO INTERNATIONAL USA, INC. FT. LAUDERDALE, FL 33301***MADE IN CHINA*** ROUNDY'S***205049***8 84118 12366 6***" Best by Date Jun 24, 2012 and Batch #047 06 25 Class II Atico International USA, Inc. is recalling Roundy's Rich Fields Butter Cookies due to Toxigenic Bacillus cereus found in a sample tested by FDA. Atico International USA, Inc.
Devices ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Product Code: 95221-35, Unit Code: 90372 Class III The impacted product was not intended for commercial distribution to end users. Kimberly-Clark Corporation
Devices Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers. Model 324JL S/N 120142 and S/N 120144 Class III A shipment mix-up took place. Impact Instrumentation, Inc.
Food Carob Raw Powder Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. P351, Lot 120056. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Chicory Root Roasted Granules Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. G440, Lot 120056. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Green Tea, Gunpowder C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. C837, lot 100181. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Fennel Seed, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W170, Lot 110155 Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Hops Flower; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W890, Lot 110020 Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Marigold Petals Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W1087, Lot 100196. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Lavender Flower Medium Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W985, Lot 120033; Also lot 110200 and 120004. W980, Lot 110200 Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Olive Leaf Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W01119, Lot 090286. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Paprika Sweet Powder; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. P1251, Lot 090048 Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Parsley Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. C1255, Lot 110107. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Pau D'Arco Bark C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. C1270, Lot 100266. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Rose Hips Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W01430, Lot 090324. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Rosemary Leaf Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Product No. W1445, Lot 010017. Product No. A330, Lot 110197, 110226, 120004. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Senna Pods Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. W1520, Lot 110220. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Spearmint Leaf Organic C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. CO1565, Lot 110171. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Thyme Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. C1631, Lot 110197. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Olive Leaf Organic; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 100275. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Paprika Sweet Flakes; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 100032. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Licorice Root, WHL; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 120019. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Peppermint lf, org C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 110171. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Tea green, Gun Powder, C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 100101. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Tea black, China T/B Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 100981. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Organic Yerba Mate; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot GTA10-01/12.. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Peppermint Leaf Organic, Large Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 100275. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Spearmint LF/CS; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 110125. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Mullein Leaf, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 110200. Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Peppermint Leaf Organic C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Lot 110171, Product No. CO1310 Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Food Spearmint Leaf C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. Product No. C1565, Lot No. 110128 Class II CA Department of Public Health inspectors found a pervasive infestation of mice in the facility. San Francisco Herb & Natural Food Company
Devices Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. 05666678001 Class II When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order. Roche Molecular Systems, Inc.
Devices S-Rom® Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial® Liner is part of the S-ROM® Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM® stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom® stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685 Class II Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue. DePuy Orthopaedics, Inc.
Food Dietary supplement. Product is labeled as :" Rescue Me***911 Damage Control***brantley living herbal formulas***HERBAL SUPPLEMENT 15 INDIVIDUAL PACKETS 4 VEGAN CAPSULES PER PACKET (2-368mg/2-584mg Each)***DISTRIBUTED EXCLUSIVELY BY: Living Herbal Pharmacy, LLC PO Box 56-2410, Miami, FL 33256-2410***". LOT 2448 BEST BY 10/12 Class II The firm recalled because the product lot contained mispackaged product wherein some capsules were missing from the finished packaged product. GMP Laboratories of America Inc
Food "Tres Monjitas***Pineapple and guava beverage***Distribuido por Vaquería Tres Monjitas Inc***" Package sizes: gallons, 1/2 gallons, quarts, 14 oz and 8 oz. No codes Class I Juice beverage contains undeclared allergenic sub-ingredient (sodium caseinate). Vaqueria Tres Monjitas, Inc.
Food Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada. Manufacturing Date 01/SEP/11; Use Before 31/AUG/12 Class I Product contains milk products and labeling does not declare milk as an ingredient. Milk is an allergen. Singh And Singh Distributors Inc.
Food Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada. Manufacturing Date 20/JUL/12; Use Before 19/JUL/13. Class I This recall has been initiated as a precaution due to Non-Declared Milk. Certain packages may be packaged with ingredient statements not labeled to include the milk ingredient. Indian Foods & Spices, LLC
Devices The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. All lots distributed from May 5, 2007 Class II Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result. Bio-Rad Laboratories
Devices HALO Flex Energy Generators Manufactured by BÂRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus. Model numbers 1190A-115A and 1190A-230A; all serial numbers. Class II Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care. Covidien LLC
Food R&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag. No UPC or manufacturing code used. Class II Product contains undeclared FD&C Yellow # 6. R & S Mexican Food Products, Inc
Devices Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003 Class II Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm. Philips Healthcare Inc.
Devices Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Serial Number range:03110101 through 11111174 Distributed from: Nov 2003 to Nov 2011 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Instrumentation Laboratory Co.
Devices Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Instrumentation Laboratory Co.
Devices Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Serial Number range: 06020101 through 10080662 Distributed between: Feb 2006 to Aug 2010 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Instrumentation Laboratory Co.
Devices Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Serial Number range: 08120100 through 12060145 Distributed between: Dec 2008 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Instrumentation Laboratory Co.
Devices Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Serial Number range: 08010100 through 12062270 Distributed between: Jan 2008 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Instrumentation Laboratory Co.
Devices Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Serial Number range: 09120101 through 12060240 Distributed between: Dec 2009 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Instrumentation Laboratory Co.
Devices ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur® Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29 Class III ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29 Class III ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 Siemens Healthcare Diagnostics, Inc
Devices Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine. Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782, 021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266. Class II This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch. Tedan Surgical Innovations Llc
Devices Precise Digital Accelerator Delivery of radiation to defined target volumes 151587, 105932, 151574, 151363, 151076, 151110, 151369, 151504, 105941, 151418, 151674, 151566, 151259, 151636, 151568, 151390, 151258, 151584, 151391, 151317, 151522, 151055, 151423, 151507, 151623, 151627, 151640, 151479, 151340, 151178, 151467, 151514, 151051, 151411, 151216, 151430, 151173, 151616, 151595, 151141, 151433, 151611, 151151, 151653, 151515, 151360, 151675, 151538, 151024, 151523, 151521, 151260, 151519, 151432, 151410, 151371, 151084, 151435, 151387, 151530, 151328, 151176, 151080, 151626, 151567, 151598, 151601, 151269, 151396, 151557, 151558, 105982, 151160, 151634, 151394, 151398, 151540, 151632, 151446, 151301, 151038, 151441, 151256, 151168, 151156, 151157, 151155, 151579, 151412, 105984, 151053, 151359, 151585, 151326, 151327, 151443, 151250, 151130, 151245, 151416, 151664, 151672, 151074, 151352, 151298, 151545, 151628, 105803, 151362, 151073 Class II There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. Elekta, Inc.
Devices Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature. Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817 Class II Unit fails to power up, resulting in an equipment alarm Zoe Medical Incorporated
Food ProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677) Lot numbers PP04024109A, PP04024109B, PP04024109C, PP04024109D, PP04024109E, PP04024109F, PP04024109G, PP04424113, PP04724115, PP08924121, PP10324131A, PP10324131B, PP11624134B, PP11624134C, PP11624134A, PP12424139, PP12924140, PP15924145B, and PP15924145A. Class II Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum Protica, Inc
Food ProBalance Protein To Go(TM), Caffeinated French Vanilla Latte, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677) Lot numbers PP25114066A, PP25114066B, PP28414079, PP29114086, PP34014103, PP04424112, PP09324122, PP09524125, PP10224129, PP11524133A, PP11524133B, PP11524133C, PP12224138A, PP12224138B, PP12224138, PP12924141, PP15924146A, and PP16024146B. Class II Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum Protica, Inc
Food Protein Wave 15 grams of protein, Tropical Fruit Gelatin (Responsible firm on label: Nutritional Resources, Inc., 5003 Wrightsboro Road, Grovetown, GA 30813) Lot number PP12426123 Class II Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum Protica, Inc
Food Protein Shots, Orange Sunshine Flavor, 2.9 fl oz (Responsible firm on label: Body Choice Nutrition, Inc., 1595 Peachtree Park Way, Suite 204, Cumming, GA 30041) Lot number PP35412924 Class II Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum Protica, Inc
Food Whole Cantaloupe. Both unlabeled and labeled "MIDWEST BEST" PRODUCE INC. HOMEGROWN CANTALOUPE #4319 PRODUCT OF THE USA none or #4319 Class I Chamberlain Farm Produce, Inc., of Owensville, Indiana, is voluntarily recalling all of its cantaloupes from the 2012 growing season that may remain in the marketplace. This recall is occurring because of concern some that cantaloupes may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Chamberlain Farms Inc.
Drugs ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA Product code 260415, Lot#: 48225 Class II Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging. Carefusion 213, Llc
Food Spence & Co Ltd brand 8oz Smoked Salmon Trim Lot Number: 6704701 Class I Product tested positive for Listeria monocytogenes Spence & Co., Ltd.
Food Wellsley Farms 1 LB Nova Salmon Lot Number: 6704701 Class I Product tested positive for Listeria monocytogenes Spence & Co., Ltd.
Devices Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes All lot numbers from 2002 to current Class II T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated Integra LifeSciences Corporation
Devices Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes All lot numbers from 2002 to current Class II T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated Integra LifeSciences Corporation
Food Watermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032. PLU 4032, Bill of Lading numbers: 8601, 8492, 27541, 27542, 27543, 27544 and 9276. Class II Unapproved pesticide residue was detected. Tunnel Farms
Food Red Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the following configurations: One Pound Pac: Red and white Plastic bag with a window to display licorice twists. UPC 0 41364 00283 5; 5 oz Black Licorice Tray Pack; UPC 4136451277 and 4136450277; 7 oz Black Licorice Laydown Bag: UPC 4136454347: 8 oz Jumbo Black twists hanging bag; UPC 4136400231; 2.5 oz Black Licorice Bar; 4 lb Black Licorice Jar, UPC 413400103; Ingredients: Molasses, Wheat Flour, corn Syrup, Caramel Coloring, Licorice Extract, Salt and Anise Flavor. American Licorice Company Union City, CA All candy Class II CA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product. American Licorice Co
Food RED VINES Mixed Bites; Red and Black licorice mixed bites. UPC: 4136400288 and 4136451277. Family Mix Half Pallet; UPD 4136421697; Family Mix PDQ; UPC 4136455297; Mixed Original Red/Black Licorice Bag Pallet; UPC 413466283; Family Mix 1/4 pallet; UPC 4136424097; 96/5 ox mixed floor display; UPC 4136454279; Mixed 4 lb Jar Pallet 120 original Red/30 Black licorice; UPC 4136421543; Family Mix Pallet: UPC 3146436097; American Licorice Company Union City, CA All candy Class II CA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product. American Licorice Co
Food Original Snaps Classic Chewy Candy; packed in 5.5 oz bags, 4.5 oz theatre box and 12 oz. tins. UPC 5.5 oz - 4136408300; 4.5 oz Theatre Box UPC 4136408302; Theatre box shipper UPC 4136408295. 12 oz tin UPC 4136408299; American Licorice Company Union City, CA All candy Class II CA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product. American Licorice Co
Food Friendly's Sundae Nut Football Limited Edition, 48 oz. carton UPC :0-29839-00530-7 Lot Codes: WC5 06/20/13 XXXX XXXXXX and WC5 07/08/13 XXXX XXXXXX Class II Product contains foreign material Friendly Ice Cream Corp.
Food Friendly's Fudge Nut Brownie Sundae Extreme, 48 oz. carton UPC: 0-29839-00657-1 Lot Code: WC5 06/01/13 XXXX XXXXXX Class II Product contains foreign material Friendly Ice Cream Corp.
Food Friendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Caramel Nut Sundae, 6 0z cup UPC 0-41497-01573-3 Lot Code: 06/11/13 Class II Product contains foreign material Friendly Ice Cream Corp.
Devices Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk. Lots AW916102A Class II The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. Kimberly-Clark Corporation
Devices Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk. Lots AW916002A, AW916102D Class II The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. Kimberly-Clark Corporation
Devices Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG). Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298, Class II Shipped with incorrect software ZOLL Medical Corporation
Devices The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. System Code #, 728246, Serial #, 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555 Class III Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button. Philips Medical Systems (Cleveland) Inc
Devices Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system. Domestic - 1493-000275, 1493-000276, 1493-000277, 1493-002469, 1493-002616, 1493-003358, 1493-003359, 1493-003667, 1493-003668, 1493-003669, 1493-003670, 1493-003671, 1493-003672, 1493-003673, 1493-003674, 1493-003675, 1493-003676, 1493-003677, 1493-003678, 1493-003679, 1493-003680, 1493-003681, 1493-003682, 1493-003683, 1493-003684, 1493-003685, 1493-003686, 1493-003687, 1493-003688, 1493-003693, 1493-003694, 1493-003695, 1493-003696, 1493-003697, 1493-003879, 1493-003880, 1493-003881, 1493-003882, 1493-003883, 1493-003884, 1493-003885, 1493-003886, 1493-003887, 1493-003888, 1493-003889, 1493-003890, 1493-003891, 1493-003892, 1493-003893, 1493-003894, 1493-003895, 1493-003896, 1493-003897, 1493-003898, 1493-003899, 1493-003900, 1493-003901, 1493-003902, 1493-003903, 1493-003904, 1493-003905, 1493-003906, 1493-003907, 1493-003908, 1493-003909, 1493-003914, 1493-003915, 1493-003916, 1493-003917, 1493-003918, 1493-003919, 1493-003920, 1493-003921, 1493-003922, 1493-003923, 1493-003924, 1493-003925, 1493-003926, 1493-003927, 1493-003928, 1493-003929, 1493-003930, 1493-003931, 1493-003932, 1493-003933, 1493-003934, 1493-003935, 1493-003936, 1493-003937, 1493-003938, 1493-003939, 1493-003940, 1493-003941, 1493-003942, 1493-003943, 1493-003944, 1493-003945, 1493-003957, 1493-003958, 1493-003959, 1493-003960, 1493-003961, 1493-003962, 1493-003963, 1493-003964, 1493-003965, 1493-003985, 1493-004007, 1493-004011, 1493-004023, 1493-004026, 1493-004027, 1493-004028, 1493-004029, 1493-004030, 1493-004031, 1493-004032, 1493-004033, 1493-004034, 1493-004043, 1493-004044, 1493-004047, 1493-004048, 1493-004050, 1493-004051, 1493-004052, 1493-004053, 1493-004054, 1493-004055, 1493-004056, 1493-004058, 1493-004060, 1493-004064, 1493-004067, 1493-004068, 1493-004069, 1493-004070, 1493-004071, 1493-004075, 1493-004084, 1493-004085, 1493-004086, 1493-004106, 1493-004112, 1493-004113, 1493-004114, 1493-004115, 1493-004116, 1493-004117, 1493-004118, 1493-004119, 1493-004120, 1493-004121, 1493-004122, 1493-004123, 1493-004124, 1493-004125, 1493-004126, 1493-004127, 1493-004128, 1493-004130, 1493-004158, 1493-004159, 1493-004160, 1493-004161, 1493-004162, 1493-004163, 1493-004164, 1493-004172, 1493-004173, 1493-004174, 1493-004175, 1493-004176, 1493-004177, 1493-004178, 1493-004179, 1493-004180, 1493-004181, 1493-004182, 1493-004183, 1493-004184, 1493-004185, 1493-004205, 1493-004206, 1493-004207, 1493-004208, 1493-004209, 1493-004210, 1493-004211, 1493-004212, 1493-004214, 1493-004215, 1493-004216, 1493-004217, 1493-004218, 1493-004219, 1493-004220, 1493-004221, 1493-004222, 1493-004223, 1493-004224, 1493-004225, 1493-004226, 1493-004227, 1493-004228, 1493-004229, 1493-004230, 1493-004231, 1493-004232, 1493-004233, 1493-004234, 1493-004235, 1493-004236, 1493-004237, 1493-004238, 1493-004239, 1493-004240, 1493-004241, 1493-004242, 1493-004243, 1493-004256, 1493-004257, 1493-004258, 1493-004259, 1493-004260, 1493-004261, 1493-004262, 1493-004263, 1493-004264, 1493-004265, 1493-004266, 1493-004267, 1493-004268, 1493-004269, 1493-004270, 1493-004271, 1493-004272, 1493-004273, 1493-004274, 1493-004275, 1493-004276, 1493-004277, 1493-004278, 1493-004279, 1493-004280, 1493-004281, 1493-004282, 1493-004283, 1493-004284, 1493-004285, 1493-004286, 1493-004287, 1493-004288, 1493-004289, 1493-004290, 1493-004291, 1493-004292, 1493-004293, 1493-004294, 1493-004295, 1493-004296, 1493-004297, 1493-004298, 1493-004299, 1493-004301, 1493-004302, 1493-004306, 1493-004307, 1493-004308, 1493-004309, 1493-004310, 1493-004311, 1493-004312, 1493-004313, 1493-004314, 1493-004315, 1493-004316, 1493-004317, 1493-004318, 1493-004319, 1493-004320, 1493-004321, 1493-004322, 1493-004323, 1493-004324, 1493-004325, 1493-004326, 1493-004327, 1493-004328, 1493-004329, 1493-004330, 1493-004331, 1493-004332, 1493-004333, 1493-004334, 1493-004335, 1493-004336, 1493-004337, 1493-004338, 1493-004339, 1493-004340, 1493-004341, 1493-004342, 1493-004343, 1493-004344, 1493-004345, 1493-004346, 1493-004347, 1493-004348, 1493-004349, 1493-004350, 1493-004351, 1493-004352, 1493-004353, 1493-004354, 1493-004355, 1493-004356, 1493-004357, 1493-004358, 1493-004359, 1493-004360, 1493-004361, 1493-004362, 1493-004363, 1493-004364, 1493-004365, 1493-004366, 1493-004367, 1493-004368, 1493-004369, 1493-004370, 1493-004371, 1493-004372, 1493-004373, 1493-004374, 1493-004375, 1493-004376, 1493-004377, 1493-004378, 1493-004379, 1493-004380, 1493-004381, 1493-004382, 1493-004383, 1493-004384, 1493-004385, 1493-004405, 1493-004406, 1493-004407, and 1493-004408. International - 1493-002941, 1493-003666, 1493-003689, 1493-003690, 1493-003691, 1493-003692, 1493-003910, 1493-003911, 1493-003912, 1493-003913, 1493-003946, 1493-003947, 1493-003948, 1493-003949, 1493-003950, 1493-003951, 1493-003952, 1493-003953, 1493-003954, 1493-003955, 1493-003956, 1493-003966, 1493-003967, 1493-003968, 1493-003969, 1493-003970, 1493-003971, 1493-003972, 1493-003973, 1493-003974, 1493-003975, 1493-003976, 1493-003977, 1493-003978, 1493-003979, 1493-003980, 1493-003981, 1493-003982, 1493-003983, 1493-003984, 1493-003986, 1493-003987, 1493-003988, 1493-003989, 1493-003990, 1493-003991, 1493-003992, 1493-003993, 1493-003994, 1493-003995, 1493-003996, 1493-003997, 1493-003998, 1493-003999, 1493-004000, 1493-004001, 1493-004002, 1493-004003, 1493-004004, 1493-004005, 1493-004008, 1493-004009, 1493-004010, 1493-004012, 1493-004013, 1493-004014, 1493-004015, 1493-004016, 1493-004017, 1493-004018, 1493-004019, 1493-004020, 1493-004021, 1493-004022, 1493-004024, 1493-004025, 1493-004035, 1493-004036, 1493-004037, 1493-004038, 1493-004039, 1493-004040, 1493-004041, 1493-004042, 1493-004045, 1493-004046, 1493-004065, 1493-004066, 1493-004072, 1493-004073, 1493-004074, 1493-004076, 1493-004078, 1493-004079, 1493-004080, 1493-004081, 1493-004083, 1493-004087, 1493-004088, 1493-004089, 1493-004090, 1493-004091, 1493-004092, 1493-004093, 1493-004094, 1493-004095, 1493-004096, 1493-004097, 1493-004098, 1493-004099, 1493-004100, 1493-004101, 1493-004102, 1493-004103, 1493-004104, 1493-004105, 1493-004107, 1493-004108, 1493-004109, 1493-004110, 1493-004111, 1493-004129, 1493-004131, 1493-004132, 1493-004133, 1493-004134, 1493-004135, 1493-004136, 1493-004137, 1493-004138, 1493-004139, 1493-004140, 1493-004141, 1493-004142, 1493-004143, 1493-004144, 1493-004145, 1493-004146, 1493-004147, 1493-004148, 1493-004149, 1493-004150, 1493-004151, 1493-004152, 1493-004153, 1493-004154, 1493-004155, 1493-004165, 1493-004166, 1493-004167, 1493-004168, 1493-004169, 1493-004170, 1493-004171, 1493-004186, 1493-004187, 1493-004188, 1493-004189, 1493-004190, 1493-004191, 1493-004192, 1493-004193, 1493-004194, 1493-004195, 1493-004196, 1493-004197, 1493-004198, 1493-004199, 1493-004200, 1493-004201, 1493-004202, 1493-004203, 1493-004204, 1493-004300, 1493-004304, 1493-004305, and 670-1350-00. Class II There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing. Spacelabs Healthcare, Llc
Devices Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light. Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852 Class II The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101. Haag-Streit USA Inc
Devices MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system. System Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E100006, EP16E100008- EP16E100063, EP16E100067, EP16E100069- EP16E100113, EP16E110001- EP16E110065, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083- EP16E110085, EP16E110088- EP16E110112, EP16E110115- EP16E110119, EP16E120001- EP16E120014, EP16E120016, EP16EB110003- EP16ER100007, EP16ER110003, EP16ER110006, P16C080001, P16C080002, P16C090001, P16C100001-P16C100015, P16C100017, P16C100018, P16C110001- P16C110008, P16C110011-P16C110037, P16C120001-P16C120003, P16C120006, P16C120007, P16E080005, P16E080007, P16E080008, P16E080012, P16E090002-P16E090021, P16E090024-P16E090028, P16E100002, P16EF80010, P16EM08003, and P16EM09002-P16EM09004. System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003-EP16ER100005, EP16ER100008, EP16ER110004, EP16ER110005, and EP16ER110007-EP16ER110024. Class II On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. Philips Medical Systems (Cleveland) Inc
Devices Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use. Lot Numbers: 120425 and 120601 Class II SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions. Sekisui Diagnostics Llc
Devices Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. LIST OF SERIAL NUMBERS: H140863 ,H294608 ,H294669 ,H294732 ,H140865 ,H294610 ,H294670 ,H294733 ,H140866 ,H294611 ,H294671 ,H294734 ,H140867 ,H294612 ,H294672 ,H294735 ,H140868 ,H294613 ,H294673 ,H294736 ,H140869 ,H294614 ,H294674 ,H294737 ,H140870 ,H294615 ,H294675 ,H294738 ,H140871 ,H294616 ,H294676 ,H294739 ,H140872 ,H294617 ,H294677 ,H294740 ,H140873 ,H294618 ,H294678 ,H294741 ,H140874 ,H294619 ,H294679 ,H294742 ,H140875 ,H294620 ,H294680 ,H294743 ,H140876 ,H294621 ,H294681 ,H294744 ,H140877 ,H294622 ,H294682 ,H294745 ,H140878 ,H294623 ,H294683 ,H294746 ,H140879 ,H294624 ,H294684 ,H294747 ,H140880 ,H294625 ,H294685 ,H294748 ,H140881 ,H294626 ,H294686 ,H294749 ,H140882 ,H294627 ,H294687 ,H294750 ,H140883 ,H294628 ,H294688 ,H294751 ,H140884 ,H294629 ,H294689 ,H294752 ,H140885 ,H294630 ,H294690 ,H294753 ,H140886 ,H294631 ,H294691 ,H294754 ,H140887 ,H294632 ,H294692 ,H294755 ,H140888 ,H294633 ,H294693 ,H294756 ,H140889 ,H294634 ,H294694 ,H294757 ,H140890 ,H294635 ,H294695 ,H294758 ,H140891 ,H294636 ,H294696 ,H294759 ,H140892 ,H294637 ,H294697 ,H294760 ,H140893 ,H294638 ,H294698 ,H294761 ,H140895 ,H294639 ,H294699 ,H294762 ,H140896 ,H294640 ,H294700 ,H294763 ,H140897 ,H294641 ,H294701 ,H294764 ,H140898 ,H294642 ,H294702 ,H294765 ,H140899 ,H294643 ,H294704 ,H294766 ,H140900 ,H294644 ,H294705 ,H294767 ,H181175 ,H294645 ,H294706 ,H294768 ,H181176 ,H294646 ,H294707 ,H294769 ,H181177 ,H294647 ,H294708 ,H294770 ,H181178 ,H294648 ,H294709 ,H294771 ,H181179 ,H294649 ,H294710 ,H294772 ,H181180 ,H294650 ,H294711 ,H181181 ,H294651 ,H294712 ,H181182 ,H294652 ,H294713 ,H181183 ,H294653 ,H294714 ,H181184 ,H294654 ,H294715 ,H181185 ,H294655 ,H294716 ,H181186 ,H294656 ,H294717 ,H181187 ,H294657 ,H294718 ,H181188 ,H294658 ,H294719 ,H181189 ,H294659 ,H294720 ,H181190 ,H294660 ,H294722 ,H181191 ,H294661 ,H294723 ,H181192 ,H294662 ,H294724 ,H182000 ,H294663 ,H294726 ,H182001 ,H294664 ,H294727 ,H182002 ,H294665 ,H294728 ,H182003 ,H294666 ,H294729 ,H182005 ,H294667 ,H294730 ,H294607 ,H294668 ,H294731 Class II Some X-jaws (lower collimator jaw) carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. If both jaw carriers on the same X-jaw were to crack, the jaw would be able to move freely in the closed direction. In this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry; Treatment after such a failure occurs may lead to an under-dose of the intended target volume. This condition was found on some machines. Varian Medical Systems, Inc. Oncology Systems
Food Fresh Tropical Fruit Mix has the Item # 027-01480, and the UPC is 0 45009 01480 1. Haggen Label reads in part "HAGGAEN'S ORIGINAL *** Tropical Mixed Fruit *** Ingredients: Fresh Pineapple, Papaya, Mango & Kiwi ***Distributed with Pride by: Haggen, Inc., Bellingham, WA *** Net Weight 8 oz. ( 227 g.)***". Use-By date range 7/21/12-8/29/12 Class I Daniella brand mangos are recalled because they may be contaminated with Salmonella. Triple B Corporation - Charlie's Produce
Food Cut Tropical Mixed Fruit has the item #028-00165 and the UPC is 0 45009 00165 8. Metropolitan Market Label is read in part " Cut Mango / Papaya w/ Lime Net Weight 10 oz (284 g.) Distributed By metropolitan market *** Seattle, WA***". Use By 7/21/12 through 8/29/12 Class I Daniella brand mangos are recalled because they may be contaminated with Salmonella. Triple B Corporation - Charlie's Produce
Food Cut Seasonal Fruit -Item # 028-00172 - Net Weight 20 oz UPC 045009 00172 6; Cut Seasonal Fruit - Item # 028-00173 - Net Weight 10 oz UPC 0 45009 00173 3; Label reads in part "CUT SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi*** Distributed By metropolitan market *** Seattle, WA***"; Seasonal Fruit - Item # 028-06037 - Net Weight 10 oz UPC 0 45009 06037 2; Seasonal Fruit - Item # 028-06454 - Net Weight 20 oz UPC 0 45009 06454 7. Label reads in part "SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi*** Produced by: Real Foods *** Kent, WA***" Use By 7/21/12 through 8/29/12 Use By 7/21/12 through 8/29/12 Class I Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella. Triple B Corporation - Charlie's Produce
Food Seasonal Berries with the Item # 028-02071 and the UPC for case 0 45009 02063 5, UPC for package 0 45009 02017 8; Case label reads in part "***ALASKA CARROT Seasonal Berries 6/8 oz *** Packed By: Charlie's Produce, Anchorage, AK***"; Package label reads in part "***Seasonal Berries Blueberry: USA Strawberry, Mango: Mexico Kiwi: New Zealand***" . Seasonal Berries with the item # 028-02063, and the UPC for case 0 45009 02063 5, UPC for package 0 45009 0206305; Case label reads in part "***ALASKA CARROT Seasonal Berries 6/16oz *** Packed By: Charlie's Produce, Anchorage, AK***"; Package label reads in part "*** 16 oz Seasonal Berries Blueberry: USA Pineapple: Costa Rica Mango: Mexico Kiwi: New Zealand***" . Use By 7/21/12 through 8/31/12 Class I Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella. Triple B Corporation - Charlie's Produce
Food Fruit Bowls: 1) Seasonal Fruit Bowl (Walmart) Item # 028-06480***" and the UPC of the package is 0 45009 06480 6 and Case UPC is 0 45009 06480 6. Case label reads in part "***ALASKA CARROT Seasonal Fruit Bowl 6/40 oz *** Packed By: Charlie's Produce, Anchorage, AK***" Use By 7/21/12 through 8/31/12; Package label reads in part "*** Fruit Bowl Gold Pineapple, Cantaloupe, Red Grapes, Strawberry Mango and Kiwi *** PRODUCT OF: Blueberry: USA Strawberry: Mexico Mango: Mexico Kiwi: New Zealand 2) Gourmet Fruit Bowl has the Item # 028-006693, and UPC 6 97327 06693 4. Label reads in part "*** ALASKA CARROT *** FRESH Sliced FRUIT *** ANCHORAGE, AK***" "*** 64oz Gourmet Fruit Bowl Gold Pineapple, Cantaloupe, Red Grapes, Strawberry Mango and Kiwi***" "PRODUCT OF: Pineapple - COSTA RICA Cantaloupe - USA Red Grapes - USA Mangoes - Mexico Kiwi - NEW ZELAND Strawberry - USA ***" "*** Packed By: Charlie's Produce, Anchorage, AK***". 1) Use By 7/21/12 through 8/31/12; 2) Use By 7/21/12 through 9/05/12 Class I Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella. Triple B Corporation - Charlie's Produce
Food Fruit Cup has Item # 028-07140, and the UPC 0 45009 07140 8. Label reads in part "*** ALASKA CARROT Fruit Cup Mango / Red Grape 42/4 oz *** Packed By: Charlie's Produce, Anchorage, AL***". Use By 8/22/12 through 9/01/12. Use By 8/22/12 through 9/01/12 Class I Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella. Triple B Corporation - Charlie's Produce
Food Tropical Salsa Product is labeled in part: "***FRESH***Garden Highway***Fresh Party Favorites!***PERISHABLE***KEEP REFRIGERATED***Tropical Salsa***Net Wt. 11 oz (312 g)***Best if Sold By***Renaissance Food Group LLC***Rancho Cordova, CA 95670***1-888-4 -HWYFUN***www.gardenhighway.com***" 8/31/12 and 9/1/12 Class I World Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only. World Food LLC.
Food Fresh Fruit Product is labeled in part: "***Fresh Island Medley***1 LB (454g)***Best If Sold By***Ingredients: Pineapple, Mango, Papaya.***Packed in its own juice***Distributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254***For Nutrition Information Call 1-888-449-9386***P-009***0 21140 01696 6***PERISHABLE KEEP REFRIGERATED***" 8/30/12 and 8/31/12 Class I World Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only. World Food LLC.
Food Fresh Fruit Product is labeled in part: "***Fruit Burst Bowl***1 LB (454g)***Best If Sold By***Ingredients: Watermelon, Cantaloupe, Pineapple, Honeydew, Grapes, Mango, Blueberries.***Packed in its own juice***Distributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254***For Nutrition Information Call 1-888-449-9386***P-009***0 21140 01701 7***PERISHABLE KEEP REFRIGERATED***" Recalled Products: UPC 0 21140 01701 7 1 LB and UPC 0 21149 01707 9 1.5 LB 1 lb: 8/30/12 and 8/31/12 1.5 lb: 8/30/12 and 8/31/12 Class I World Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only. World Food LLC.
Food Mango Spears: 1) Delish Mango Spears Net Wt. 5 oz. (142 g) Enjoy by: 8/28/2012 and before Prepared for Walgreens Inc. Deerfield, Illinois 60015 Distributed by Walgreens UPC 0 49022 53700 2; Delish Mango Spears 1 lb .(454 g) UPC 0 49022 58823 3 2) Mango Spears Best if Sold By: 08/28/12 and before 16 oz (1 lb) Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 Enjoy by: 8/28/2012 and before Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Delish Pineapple, Mango and cantaloupe Spears Net Wt. 5 oz. Enjoy by: 8/28/2012 and before Prepared for: Walgreens Inc. Deerfield, Illinois, 60015 Distributed by Walgreens UPC 0 49022 537019 Enjoy by: 8/28/2012 and before UPC 0-49022-53701-9 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Delish Fruit Burst 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 049022 55862 5 Enjoy by: 8/28/2012 UPC 0 49022 55862 5 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Delish Tropical Medley 10 oz.(283 g) Enjoy by: 8/28/12 and before Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 04 902253699 9 Enjoy by: 8/28/2012 and before UPC 0 4902253699 9 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Delish Mango & Berry Mix 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 0 49022 63779 5 Enjoy by: 8/28/2012 UPC 0 49022 63779 5 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Garden Highway Fresh Fruit Mango Medley 1 lb .(454 g) Best if sold by: 8/28/12 and before Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 21437 2 Best if sold by: 8/28/12 and before UPC 8 26766 21437 2 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Garden Highway Tropical Mango Spinach Salad with Zesty Orange Vinaigrette 7 oz .(198 g) Best if sold by: 8/28/12 and before Distributed by: Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 801850 5 Best if sold by:8/28/12 and before UPC 8 26766 801850 5 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Garden Pure Fresh Cut Mango 9 oz .(255 g) Best By: 08/28/12 and before Packed by F& S Produce Co. Inc. Headquarters, Rosehayn, NJ 06532 UPC 8 01172 20149 5 Best By: 08/28/12 and before UPC 8 01172 20149 5 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Fresh Cut Fruit Mango Chunks 1/5 lbs Best Use By: 08/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 No UPC Best if sold by: 8/28/12 and before No UPC Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Garden Pure Mixed Fruit Net Wt. 48 oz (1.36 kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 6 001172 00264 1 Best By: 8/28/12 and before 6 001172 00264 1 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Garden Pure Holiday Fruit Bowl 4 lbs (1.81kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 UPC 6 01172 00264 1 Best By: 8/28/12 and before UPC 6 01172 00264 1 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food SIgnature Cafe Fruit Basket Medley, 30 oz, Use By: AUG 28 12 and before Distributed by Lucerne Foods, Inc., PO Box 99, Pleasonton, CA 94566-0009 1-877-232-4271 UPC 0 2113006918 7 Use By: AUG 28 12 and before UPC 0 2113006918 7 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Food Trader Joe's Tropical Fruit Medley, 16 oz, Best By: 08/28/12 and before Dist. & Sold exclusively by: Trader Joe's, Monorovia, CA 91016 UPC 00949361 Best By: 08/28/12 and before UPC 00949361 Class I F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella. F & S Produce Co., Inc. (Site II)
Devices Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. Lot # HUWE1779 Class II Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product Davol, Inc., Subs. C. R. Bard, Inc.
Devices Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. Lot # HUWE1780 Class II Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh Davol, Inc., Subs. C. R. Bard, Inc.
Food Somersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Salt Flavor, Net Wt. 6 oz. UPC 8-98403 00201-7; Sell By Date MAR1113 G6. Class I Consumer complaints and subsequent investigation found that packages of Pacific Sea Salt snack crackers had some Santa Fe Salsa snack crackers mixed in. Santa Fe Salsa crackers contain milk protein which is not declared on the ingredient labeling. Somersault Snack Co., LLC
Devices Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections. 250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012 Class II Embedded iron oxide glass defect which may have the potential to break off into the solution. Hospira Inc.
Drugs Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 Lot: DL11600 Exp Date: 06/13 Class III Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. Apace KY LLC
Devices 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS. Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C Class II Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. Smith & Nephew Inc
Devices Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. lots 27686, 27293, 22446 Class II Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination. Vascular Solutions, Inc.
Devices 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe. KH03752 Class III One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. Amsino Medical USA
Devices 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe. KH03752 Class III One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. Amsino Medical USA
Devices The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Class II This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. RAYSEARCH LABORATORIES AB
Devices Verify® Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle. Model #S3098, Serial #"s: H20013, H20014, and H20016. Class II STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges. Steris Corporation
Devices STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery). Serial numbers from 0403809001 to 0408612102 Class II STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlocked when in fact the floor locks are engaged. Steris Corporation
Devices Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Devices Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter Lot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Devices Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter Lot numbers: 193J3R, 193M3T, and 294Q57 Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Devices Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter Lot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Devices Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter Lot number: 296S77 Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Devices Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter Lot number: 296T78 Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Devices Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter Lot numbers: 193P3V and 295P62 Class II Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. Asahi Kasei Medical Co., Ltd., Okatomi Plant
Drugs Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92, Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12 Class III Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. Sandoz Incorporated
Drugs Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92 Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12 Class III Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. Sandoz Incorporated
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