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U.S. Department of Health and Human Services

Enforcement Report - Week of February 12, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry. All Lots Class II Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection. Apothecure, Inc
Drugs Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393. Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206. Class II Marketed without an Approved NDA/ANDA. Insight Instruments, Inc.
Drugs HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433. All lots. Expiration date 09/2015. Class II Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) Health & Beyond
Drugs Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Lots: PL520, PL521, PL522 and PL523 Class II Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits. Fusion Pharmaceuticals, LLC
Drugs CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH 600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14 Class II CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension. Central Shared Services dba Parallon
Drugs Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles) Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015 Class II Failed Tablet/Capsule Specifications: Broken tablets Actavis Inc
Drugs Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11 Lot H3A744, Exp 01/15 Class I Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit. B. Braun Medical Inc
Veterinary AMIKACIN SULFATE*-PF 250MG/ML INJECTABLE Lot t10162013@20 Best By 10/30/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary BUPRENORPHINE* HCL 0.6MG/ML INJECTABLE Lot 10112013@2 Best By11/10/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary CYCLOSPORIN* MCT 0.2% OPHTHALMIC CYCLOSPORIN* MCT 1% OPHTHALMIC CYCLOSPORIN* MCT 2% OPHTHALMIC 0.2%: Lot t08142013@42 Best By 2/10/2014 1%: Lot t07022013@29 Best By 12/29/2013; Lot t07242013@27 Best By 1/20/2014; Lot t08282013@28 Best By 2/24/2014; Lot t10032013@10 Best By 4/1/2014 2%: Lot t08142013@36 Best By 2/10/2014 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary DESMOPRESSIN ACETATE* (0.01%) 0.1MG/ML SOLUTION DESMOPRESSIN ACETATE* (0.0125%) 0.125MG/ML DESMOPRESSIN ACETATE* (0.02%) 0.2MG/ML SOLUTION Lot 09132013@4 Best By 12/12/2013 Lot t09182013@39 Best By 12/17/2013 Lot t09032013@21 Best By 12/2/2013 Lot t07242013@22 Best By 10/22/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary DOXYCYCLINE-OS 100MG/ML VET LIQUID Lot 08092013@23 Best By 2/5/2014 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary IDOXURIDINE* OPHTHALMIC 0.1% SOLUTION L Lot t08022013@17 Best By 9/1/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary PHENOBARBITAL SODIUM* 65MG/ML INJECTABLE Lot 08192013@28 Best By11/17/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary TACROLIMUS (VET)* 0.03% OPHTH SOL TACROLIMUS* (VET) 0.02% OPHTH SOL 0.03% : Lot 08222013@17, Best By10/21/2013 t09052013@14 11/4/2013 0.02%: Lot t08272013@17, Best By10/26/2013 t09162013@20 11/15/2013 t09262013@6 11/25/2013 t09302013@31 11/29/2013 t10092013@14 12/8/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary TACROLIMUS OINTMENT 0.03% OPHTHALMIC 08122013@39 2/8/2014 t10092013@15 4/7/2014 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary TACROLIMUS* (VET) MCT 0.02% OPHTH SOL t07092013@24 Best By 9/7/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary XYLAZINE* (VET) 100MG/ML INJECTABLE t08212013@17 Best By11/20/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Biologics Platelets Pheresis Leukocytes Reduced W041013129463O; W041013129463O; Class II Blood products, with insufficient plasma to support the platelet concentrations, were distributed. Blood Systems Inc
Biologics Platelets Pheresis W158013702296; W158013702296; Class II Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. Arup Laboratories, Inc.
Drugs Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2 lot V112000, EXP Jun 2016 Class III Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval Greenstone Llc
Drugs Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66 Lot V120131 Class III Failed Dissolution Specification; 8 hr stability timepoint Pfizer Inc.
Devices Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures. lowest serial number is GN001141; the highest is GN001704 (non-consecutive) Class II The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use. Medtronic Advanced Energy, LLC
Drugs Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33 Lot 1111291 Exp. 02/16 Class III Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. Forest Pharmaceuticals Inc
Drugs Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29. Lot 1113661 Exp. 01/15 Class III Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. Forest Pharmaceuticals Inc
Drugs Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05. Lot 1112467 Exp. 02/15 Class III Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. Forest Pharmaceuticals Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037912135464; W037912135464; Class II Blood products,collected from donors who did not meet the re-entry criteria following invalid NAT testing, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W037912141508; Class II Blood products,collected from donors who did not meet the re-entry criteria following invalid NAT testing, were distributed. LifeServe Blood Center
Veterinary Cyclosporine Opthalmic (vet use) All lot numbers within expiry. Class III Sterility could not be assured. Natures Pharmacy & Compounding Center
Devices The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System. Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020 MTA7900A01024 MTA7900D01028 MTA7900F01002 MTA7900H80009 MTA7900H80021 MTA7900G90016 MTA7900H90006 MTA7900K90056 MTA7900K90061 MTA7900K90063 MTA7900L90003 MTA7900L90006 MTA7900L90020 MTA7900H80057 MTA7900E01016 MTA7900I90006 MTA7900I90038 MTA7900B90020 MTA7900E80014 MTA7900E80020 MTA7900E80027 MTA7900I90023 MTA7900I90027 MTA7900E90031 MTA7900I90031 MTA7900I90041 MTA7900H90004 MTA7900B80004 MTA7900A80028 MTA7900E80054 MTA7900E01042 MTA7900D80001  ...
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Class II Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to Auto mode, the therapy will be reset, and may potentially cause patients to reach the set point earlier. The rate of controlled rewarming is a set slope controlled by the Medi-therm unit. There is a potential that the patients passive rate of rewarming is greater than the rate-controlled rewarming. If switched out of Auto mode, the patients passive rewarming is no longer controlled by the machine, which allows the patient to rewarm at their passive rate. Once switched back into Auto mode, the machine will use the patients current temperature as the new starting temperature. The Medi-therm unit will take back control of the rate of warming. However, the patients temperature may potentially have been raised to a higher point while outside of Auto mode due to the patients passive rewarming ability. Consequently, this may result in the patient reaching the target temperature earlier than if modes had not been. Stryker Medical Division of Stryker Corporation
Drugs Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56 Lot W22042 Class II Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. Teva Pharmaceuticals USA, Inc.
Drugs 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 G105197, Exp. 02/14 Class I Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. Baxter Healthcare Corp.
Food Marina's German Bakery; Assorted Pastries; 2 pieces, Minimum Wt. 6 oz. 170 g; UPC# 010801003018; 2033 Trawood Dr., El Paso, Texas 79935 All "Sell By" dates, prior to 11/23/2013 Class I The assorted pastry products may contain undeclared hazelnuts, walnuts or almonds. These tree nuts can cause life-threatening, allergic reactions for some individuals. Marina's German Bakery
Devices ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. Lot No. 1300801 Class II Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. Horiba Instruments, Inc dba Horiba Medical
Devices CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. serial numbers: SEG09270517HX, SEG09270549HX, SEG09270551HX, SEG09270553HX, SEG09270554HX, SEG09270557HX, SEG09270559HX, SEG09270561HX, SEG09270562HX, SEG09270563HX, SEG09270564HX, SEG09270565HX, SEG09270566HX, SEG09270567HX, SEG09270568HX, SEG09270569HX, SEG09270583HX, SEG09270584HX, SEG09270585HX, SEG09270587HX, SEG09270588HX, SEG09270589HX, SEG09270591HX, SEG09270592HX, SEG09280596HX, SEG09280597HX, SEG09280598HX, SEG09280599HX, SEG09280600HX, SEG09280601HX, SEG09280602HX, SEG09280603HX, SEG09280604HX, SEG09280605HX, SEG09280606HX, SEG09280607HX, SEG09280608HX, SEG09280609HX, SEG09280610HX, SEG09280611HX, SEG09280612HX, SEG09280613HX, SEG09280614HX, SEG09280615HX, SEG09280616HX, SEG09280617HX, SEG09280618HX, SEG09280619HX,  ...
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Class II There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communication loss may occur when the PDM is first attached to the host monitor, or it may lose communication spontaneously during use with no user action. GE Healthcare, LLC
Biologics Red Blood Cells 1542583; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051513074498; W051513074498; Class II Blood products, collected on an apheresis machine undergoing validation and which did not have the required quality control testing performed, were distributed. Innovative Blood Resources
Devices Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container. N/A Class II Bicarbonate Jug Adapter distributed prior to 510(k) approval Fresenius Medical Care Holdings, Inc.
Drugs Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320 20154 EXP.12/13, 20153 EXP.12/13, 20152 EXP.12/12, 20151 EXP.12/11, 20093 EXP.12/13, 20092 EXP.12/13, 20091 EXP.12/13, 20085 EXP.12/13, 20084 EXP.12/13, 20083 EXP. 2/13, 20082 EXP.12/13, 20073 EXP. 12/13, 20074 EXP. 12/13, 20075 EXP. 12/13, 20081 EXP.12/13, 20021 EXP. 12/13 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Faria Limited LLC dba Sheffield Pharmaceuticals
Drugs FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105 20022 EXP. 12/13, 20031 EXP. 12/13, 20032 EXP. 12/13, 20041 EXP. 12/13, 20042 EXP. 12/13, 20051 EXP. 12/13, 20052 EXP. 12/13, 20061 EXP. 12/13, 20071 EXP. 12/13, 20072 EXP. 12/13 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Faria Limited LLC dba Sheffield Pharmaceuticals
Drugs Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072 20221 EXP. 04/14 Class II Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Faria Limited LLC dba Sheffield Pharmaceuticals
Biologics Red Blood Cells 2320465; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2320465; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets 2320465; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W20041380902300; Class II Blood product, which did not meet the platelet QC specification for pH, was distributed. Arc Blood Services, New England Region
Biologics Fresh Frozen Plasma 1536622; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced 1536622; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets 1536622; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells W036809291050; W036810111220; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036809811387; W036810808738; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Cryoprecipitated AHF W036810111220; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036810111220; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets Pheresis Leukocytes Reduced W037913565215; W037913564243; W037913564243; W037913565346; W037913565218; W037913565218; Class II Blood products, tested using a pH meter that had not been calibrated, were distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W201713801086; W201713801086; W201713801086; Class II Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed. American National Red Cross (The) - North Central Region
Biologics Red Blood Cells Leukocytes Reduced W071213035788; Class III Blood products, labeled with extended expiration dates, were distributed. Medic Inc
Biologics Plasma Frozen within 24 hours (FP24) W071213035788; Class III Blood products, labeled with extended expiration dates, were distributed. Medic Inc
Devices ADVIA Centaur® Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems Lot # Expiry Date 19002A58 06/09/2014; 19088A58 06/09/2014; 21376A58 06/09/2014; 25657A59 09/29/2014; 26830A59 09/29/2014; 28447A59 09/29/2014. Class II ADVIA Centaur® Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur® Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems Lot # Expiry Date 18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014. Class II ADVIA Centaur® Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. Siemens Healthcare Diagnostics, Inc
Devices ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision. Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014. Class III HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected. Horiba Instruments, Inc dba Horiba Medical
Devices Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology. models 8098027, 7740769, 10430603, 10590000, with multiple serial numbers: 64789, 64492, 66767, 66649, 64067, 66182, 65364, 64673, 64419, 66518, 66243, 64368, 64081, 60398, 66929, 66327, 66146, 66188, 66355, 66467, 64860, 64342, 73579, 73813, 64179, 66498, 64172, 66433, 66572, 66768, 64790, 66193, 64270, 66503, 65013, 65014, 64821, 64337, 64734, 65036, 66455,  ...
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Class II During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B. Siemens Medical Solutions USA, Inc
Devices MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI. Class II Manufactured with an incorrect factory set unit of measure. Nipro Diagnostics, Inc.
Devices MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI. Class II Manufactured with an incorrect factory set unit of measure. Nipro Diagnostics, Inc.
Devices Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) Model #882412; Serial #'s:14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711. Model #882438; Serial #'s:17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 1  ...
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Class II The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study. Philips Medical Systems (Cleveland) Inc
Devices B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018. Class II Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications. B. Braun Medical, Inc.
Devices Neptune 2 Rover Ultra Waste Management System. Manufacturer Part Number 0702-001-000 (120V) All serial numbers Class II The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. Stryker Instruments Div. of Stryker Corporation
Devices Neptune 2 Rover Ultra Waste Management System Manufacturer Part Number 0702-002-000 (230V) All serial numbers Class II The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. Stryker Instruments Div. of Stryker Corporation
Devices ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies. Catalog Numbers: 186-01-08, 186-01-11, 186-01-13, 186-02-08, 186-02-11, 186-02-13, 186-03-11, 186-03-08, 186-03-11, 186-03-13, 186-04-08, 186-04-11, 186-04-13, 186-05-08, 186-05-11, 186-05-13. Class II Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. Exactech, Inc.
Devices XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. MUJ Class II When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect. Elekta, Inc.
Devices Giraffe® Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe® Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Serial Numbers: HDJR52093 HDJQ52878 HDJS51010 HDJP51983 HDJN52273 HDJN52274 HDJN52275 HDJN52276 HDJP50604 HDJP50605 HDJM50388 HDJR56613 HDJQ52689 HDJR50734 HDJR50735 HDJS50028 HDJP52371 HDJP52558 HDJN51693 HDJN51694 HDJR56618 HDJQ51960 HDJS52390 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926  ...
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Class II Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. GE Healthcare
Devices Panda iRes® Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Serial Numbers: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50681 HDJS50682 HDJS50684 HDJS50686 HDJR56405 HDJS52316 HDJP51364 HDJP51369 HDJP51376 HDJP51379 HDJP51380 HDJP51381 HDJR56387 HDJR56388 HDJR56389 HDJR56390 HDJR56391 HDJR56666 HDJN50977 HDJN50978 HDJQ53071 HDJM51282 HDJM51283 HDJM51284 HDJM51285 HDJM51286 HDJM51287 HDJM51288 HDJM51289 HDJM51290 HDJM51291 HDJM51292 HDJM51293 HDJM51294 HDJM51295 HDJQ50845 HDJQ50846  ...
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Class II Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. GE Healthcare
Devices Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants. Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274 Class II Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. GE Healthcare
Devices Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s Serial Numbers: 402055 402149 402151 402155 402168 402172 402134 401758 401759 401760 401761 401762 401767 401769 401772 401775 401776 401825 401773 401777 401771 401774 401778 401766 401763 401764 401765 401768 401770 400802 400657 400434 400768 401203 401208 402081 402245 402180 401965 400493 400504 400506 401998 402345 402352 400311 401481 410773 Class II Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. GE Healthcare
Devices Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants. Serial Numbers: QABR50001 QABR50002 QABR50003 QABR50004 QABR50005 QABR50006 QABR50007 QABR50008 QABR50009 QABR50010 QABR50011 QABR50012 QABR50013 QABR50014 QABR50015 QABR50016 QABR50017 QABR50018 QABR50019 QABR50020 QABR50021 QABR50022 QABR50023 QABR50024 QABR50025 QABR50026 QABR50027 QABR50028 QABR50029 QABR50030 QABR50031 QABR50032 QABR50033 QABR50034 QABR50035 QABR50036 QABR50037 QABR50038 QABR50039 QABR50040 QABR50041 QABR50042 QABR50043 QABR50044 QABR50045 QABR50046 QABR50047 QABR50048  ...
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Class II Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. GE Healthcare
Devices Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants. Serial Numbers: 100341 100342 100348 200118 200143 200513 200522 200590 200598 200617 201111 201375 201384 201409 201424 201567 201621 201622 201625 201627 201814 202013 202021 202141 202143 202147 202280 202300 202365 202395 202439 202538 203117 203186 203419 203448 203452 203453 203755 203961 204048 204153 204154 204166 204170 204323 204333 204732  ...
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Class II Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. GE Healthcare
Food Triarco Industries, LLC an Innophos company Multicolor Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale 40421 40597 40598 40766 Class II Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol. Triarco Industries, Inc.
Food Triarco Industries, LLC an Innophos company Red Lightening Drink Granulation Notice- For manufacturing Use Only Not for Resale 40779 Class II Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol. Triarco Industries, Inc.
Food Triarco Industries, LLC an Innophos company Green Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale 40546 Class II Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol. Triarco Industries, Inc.
Food Triarco Industries, LLC an Innophos company Activessence (R) Notice- For Manufacturing Use Only Not for Resale 40829 Class II Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol. Triarco Industries, Inc.
Devices Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity. E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08 Class II ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. ITC-Nexus Dx
Food Aztec Cheddar Cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 13 lbs). Labeled in part: "367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE AZTEC CHEDDAR Raw milk, salt,***130823XCAZ" Lot #: 130823XCAZ Class I Routine testing by the GA Department of Agriculture revealed that the firm's Heavenly Blue and Aztec Cheddar products were positive for Salmonella. Flat Creek Farm & Dairy
Food Heavenly Blue cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 8 lbs). Labeled in part: "367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE HEAVENLY BLUE Raw milk, salt,***130916XHB". Lot #: 130916XHB Class I Routine testing by the GA Department of Agriculture revealed that the firm's Heavenly Blue and Aztec Cheddar products were positive for Salmonella. Flat Creek Farm & Dairy
Devices Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses. Model 7305. Lot/Serial Numbers: The catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD. Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants. Class II Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant. Medtronic Cardiovascular Surgery-the Heart Valve Division
Devices The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics. Model #209500 Class II The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient ArjoHuntleigh Inc.
Devices The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from Össur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25  30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use. Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413 Class II OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. Ossur Americas, Inc.
Devices IMPAX RIS QDOC 5.8 Software IMPAX RIS 58 and higher Class II Patient name displayed (printed) on the Patient Report was the wrong patient name. AGFA Corp.
Veterinary Cattle Feed- Tailings and Pulp from beet production bulk product manufactured from 01/04/14  01/11/14 Class III Product was prepared under insanitary conditions. Western Sugar Company
Devices 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system. Lot 009SV Class II OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524. OrthoPediatrics Corp
Devices LOCATOR® Implant Attachment System. The LOCATOR® Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR® Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878 Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893. Since  ...
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Class II Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR® Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently noted by Zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommended torque, the abutment torque value should be 20 N-cm. Zest Anchors LLC
Devices Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230. Trifurcated Extension Set, Model No. ME 1224, Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002 Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666. Class II CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak. CareFusion 303, Inc.
Biologics Sipuleucel-T 3000131; 3000221; 3000237; 3000501; 3002534; 3003761; 3003951; 3006171; 3006671; 3008071; 3008691; 3009072; 3012481; 3013795; 3022092; 3024811; 3025542; 3027702; 3030102; 3031713; 3032091; 3032163; 3033241; 3033651; 3033815; 3034311; 3035051; 3037373; 3038251; 3038252; 3039141; 3040121; 3041333; 3044111; 3044952; 3047292; 3051971; 3056722; 3061182; 3070302; 3082421; 3085442; 3076793; 3065582; 3065781; 3073441; 3090651; 3091811; 3017963; 3033041;  ...
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Class II PROVENGE, which did not meet the release spec for CD54 upregulation, or which had the potential to not meet the potency release specification for CD54 upregulation, was distributed. Dendreon Corp
Devices SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle. Lot Numbers: 13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362 Class II CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during infusion. CareFusion 303, Inc.
Devices GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. System ID Model, Catalogue or Code # 828213AIRF2 2385123-2 309454FJRM1  ...
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Class II GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. To date, no injury has been reported due to this. GE Healthcare, LLC
Devices Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation. lot 59617777 and 59658495. Class II Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping. Edwards Lifesciences, LLC
Food Lenguita Cookies net wt. 6 oz., Distributed by Mama Lycha Foods, Houston TX 77055 toll free (877)MAMALYCHA email contact@mamalycha.com www.mamalycha.com Product of Honduras No lot code Class II Product contains undeclared wheat Gotera, Inc
Devices SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position. Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper Class II Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark. Highland Metals, Inc.
Devices SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position. Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper Class II Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark. Highland Metals, Inc.
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