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U.S. Department of Health and Human Services

Enforcement Report - Week of March 12, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 36FM54379 Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. The American National Red Cross South Carolina Region
Biologics Platelets Pheresis Leukocytes Reduced 36FM54379 (2 units) Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells Leukocytes Reduced 106657699 Class III Blood product, not prepared in accordance with specifications was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 107228886(A) ;107228886(B) Class II Blood products, which did not meet acceptable product specifications, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 107198792 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 104192654 Class III Blood product, collected from an ineligible donor, was distributed. Blood Systems, Inc.
Drugs B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 Lot numbers: C02R and F03Q Class I Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug Mira Health Products Ltd.
Drugs Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433. lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown Class I Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug Mira Health Products Ltd.
Drugs METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL lot number: L54Q Class I Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug Mira Health Products Ltd.
Devices GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system Mfg Lot or Serial # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1 00000171126GE6 00000213683GE6 00000171114GE2 00000171115GE9 00000171507GE7 00000171940GE0 00000171508GE5 00000171116GE7 00000171642GE2 00000171509GE3 00000171510GE1 00000171117GE5 00000175341GE7 00000180599GE3 00000218195GE6 00000212000GE4 00000207770GE9 00000171128GE2 00000175338GE3 00000194707GE6 00000180600GE9 00000207771GE7 00000171119GE1 00000180601GE7 00000171506GE9 00000172678GE5 00000171941GE8 00000171123GE3 00000171122GE5 00000171125GE8 00000186993GE2  ...
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Class II When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate. GE Healthcare, LLC
Devices McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. MAC 14.3.1/MAC 14.3.1.1 Class I There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. MCKESSON TECHNOLOGIES INC.
Devices TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189, JDA1082190, JDA10X2191, JDA10X2192, JDA10X2193, JDA10X2194, JDA10X2195, JDA10X2196, JDA10X2197, JDA10X2198, JDA10Y2199, JDA10Y2200, JDA10Y2201, JDA10Y2202, JDA10Y2203, JDA10Y2204, JDA10Y2205, JDA10Z2206, JDA10Z2207, JDA10Z2209, JDA10Z2210, JDA10Z2211, JDA10Z2212, JDA10Z2213, JDA10Z2214, JDA10Z2215, JDA1112216, JDA1112217, JDA1112218, JDA1112219, JDA1112221, JDA1112222, JDA1112224, JDA1112225, JDA1112226, JDA1112227, JDA1122231, JDA1122234, JDA1142236, JDA1162237, JDA1162238,  ...
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Class II Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start. Toshiba American Medical Systems Inc
Biologics Cryoprecipitated AHF, Pooled 021L48171, 021L48172, 021L48173, 021L48174, 021L48175, 021L48176, 021L48177, 021L48178, 021L48179, 021L48180, 021L48181, 021L48182, 021L48183, 021L48201, 021L48202, 021L48203, 021L48204, 021L48205, 021L48206, 021L48207, 021L48208, 021L48209, 021L48210, 021L48211, 021L48212, 021L48213, 021L48214, 021L48215, 021L48216, 021L48221, 021L48222, 021L48223, 021L48224, 021L48225, 021L48226, 021L48227, 021L48228, 021L48232, 021L48233, 021L48234, 021L48235, 021L48236, 021L48237, 021L48238, 021L48239, 021L48240, 021L48251, 021L48252, 021L48253, 021L48254,  ...
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Class II Blood products, which failed the monthly quality control testing for Factor VIII level, were distributed. American National Red Cross (The)
Drugs Lidocaine 4% Urethral Gel Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Acetylcysteine 10% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs AMP/M-B12/Pyridox/Methionine Inositol All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Bladder Instillation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Bleomycin Sulfate 1unit/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyanocobalamin 100mcg/ml injection All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyano B-12 p-f 1000mcg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyano B-12 (Cmpd) 1000mcg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethasone (pf) 0.05 % opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethasone phosphate 24mg/ml inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Ethanol 20% ophthal. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs EDTA 3% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs 5-Fluorouracil pf in methocel 1% opthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs 5-Fluorouracil 1% ophthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Folic acid (pf) 10mg/cc inj All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Gentamycin 80mg/1000cc 0.9% NS All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs L-Glutathione inhalation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione 6%/ascorbic 1%/DMSO 6.25% All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione Inhalation 200mg/5ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Hydroxocobalamin inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Hydroxyprogesterone Caproate All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Idoxuridine 0.1% Ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Methotrexate Intraocular 400mcg 0.1cc All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Methylcobalamin All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Novarel (IM) All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Papaverine 1nj 30mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Papaverine 12mg/phent 1mg/Pros 9mcq/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Prostaglandin all combinations All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Pyridoxine (p-f) 100mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Renacidin Irrigation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Sodium Bicarbonate 8.4% inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Scopolamine 0.25 opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tetracaine 0.5% ophth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tacrolimus (H20-based) 0.03% ophth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tacrolimus 0.02% opth. (H20-based) All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Terbutaline/Ipratropium 0.5mg/2.5ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Testosterone Cypionate 100mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Testosterone Cypionate 200mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Triamcinolone Acetonide 3mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vancomycin (fortified) 25mg/ml opth All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vit A (olive oil) 0.1% opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vitamin D (Ergocalciferol) 800 u/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 1% opthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 0.5mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 0.5mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Devices *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system. *** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H; *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G Class II Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly. Hospira Inc.
Devices Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. Model 1.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Model 3.0 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Model 3.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Food Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds. Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti brand. NONE Class I Sampler Bag of Biscotti is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellophane - net wt. 2 oz. NONE Class I Lemon Biscotti dipped in White Chocolate Bag is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Cranberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Almond dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Almond dipped in Dark Chocolate Biscotti-individually wrapped- is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Blueberry drizzled in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Blueberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Traditional Toasted Almond Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Traditional Toasted Almond-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Alaskan Birch Brittle with Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. Alaskan Birch Brittle Drizzled in dark chocolate-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Alaska Birch with Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Hazelnut Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Hazelnut Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Mandarin Orange Tozzetti Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Devices RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. R4.2, R5.0, R5.1, R6.0, R6.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. Identifier - 6.0, 6.1.0, 7.0.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018. Class II Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. Toshiba American Medical Systems Inc
Biologics Cryoprecipitated AHF, Pooled W087613902271 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W087613553381 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W038113264435 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. OneBlood, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W038113264435 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037712017691 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036813171414 Class II Blood product, which was incorrectly labeled as leukoreduced, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813132985 Class II Blood product, which was incorrectly labeled as leukoreduced, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037713042561 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced W137513107352 Class II Blood product, collected from a donor who was taking the medication Avodart, was distributed. Lane Memorial Blood Bank
Food Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties: White Powdered Donut : Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) COATING: Dextrose, cornstarch, partially hydrogenated vegetable oil, titanium dioxide, rice flour, hydrogenated cottonseed oil, artificial flavor, silicon dioxide. Contains wheat, soy and milk no code, produced 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Chocolate Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Chocolate Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, butter (milk), chocolate drops (sugar, cocoa butter, chocolate liquor), cocoa powder, flavor salt. Contains wheat, soy and milk no code, produced 1/13/2014 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Bavarian Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Bavarian Creme Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) FILLING: High fructose corn syrup, sugar, food starch modified, palm oil, salt, titanium dioxide, agar sorbic acid, sodium benzoate, potassium sorbate, artificial flavor, modified cellulose, propylene glyocol, glycerin, corn starch, dextrose, polysorbate 80 & 60, sorbitan monostearate, sodium citrate, xanthangum, annatto, caramel color, yellow 5, yellow 6. Contains wheat, soy and milk no code, manufactured 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Apple Fritter, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Apple Fritter Enriched wheat flour, apples, soybean oil, dextrose, cinnamon, salt, leavening, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) GLAZE: Powdered sugar, conrnstarch, modified foodstarch (corn) and milk. Contains wheat, soy and milk no code, manufactured 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Caramel Donuts, sold individually and found in 6 count (436 g)UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Caramel Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, brown sugar, butter (milk), salt Contains wheat, soy and milk no codes, producte 1/13/2014 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Cinnamon Caramel Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties and in Cinnamon Caramel Donut Holes, 1.05 lb, UPC Code 6 26570 61743 3. Cinnamon Caramel Donuts, donut holes Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, brown sugar, butter (milk), dextrose, cornstarch, cinnamon, palm and soy oil, salt and flavor. Contains wheat, soy and milk no codes, manuactured 1/13/2014 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Glazed Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Glazed Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) GLAZE: Powdered sugar, cornstarch, modified foodstarch (corn) and milk. Contains wheat, soy and milk no codes, produced 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Raspberry Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Raspberry Creme Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) FILLING: Black raspberries, granulated sugar, permaflo, lemon juice and natural flavor. Contains wheat, soy and milk No codes, manufactured 1/13/2014 or before Class I Undeclared egg ingredient and undeclared Yellow # 6 and Yellow #5 Rise'n Roll Bakery, LLC
Food A. Rise n Roll Specialties, Homemade, Nutty Crunch, ..., boiled to perfection, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 3 B Simply Amish, Crunch N Nutter, Mixed Nut,... No Preservatives, ...NT. WT 4 oz. Ingredients: cashews, pecans, almonds, butter (milk) sugar. Contains Nuts, Milk, and Soy, Merrell Food Group, Inc., Dalton, WI 53926 UPC#861522000042. Rise N Roll, Nutty Crunch Best by date June 13th, 2014 or earlier Simply Amish, Crunch N Nutter, Best by date of June 1, 2014 or earlier; Class I Undeclared peanuts Rise'n Roll Bakery, LLC
Food Amish Wedding, Nutty Crunch, ... boiled to perfection, Distributed by Troyer Cheese, Inc. ... Millersburg, OH 44654, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 Best by date June 13th, 2014 or earlier Class II Undeclared peanuts Rise'n Roll Bakery, LLC
Drugs a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 Lot #: a) 79305114A, b) 79305114B, c) 79305114C, d) 79305114D, e) 79305114E, f) 79305114F, Exp 05/2015 Class II Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules. Dr. Reddy's Laboratories, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W1151132824302 Class II Blood products, for which the testing for pH was invalid, were distributed. LifeSouth Community Blood Centers Inc
Biologics Platelets Pheresis Leukocytes Reduced W1151132824302 Class II Blood products, for which the testing for pH was invalid, were distributed. LifeSouth Community Blood Centers Inc
Biologics Source Plasma TT0294494, TT0295547, TT0296098 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. DCI Biologicals Temple Terrace, LLC
Biologics Platelets Pheresis Leukocytes Reduced W229813800598 Class II Blood product, with a low platelet yield, was distributed. Blood Center of Northcentral Wisconsin, Inc.
Drugs Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11. Lot Number: 6004137, Expiration date: 06/2014 Class II Subpotent; 18 month time point Fresenius Kabi USA, LLC
Biologics Lambda Cell Tray" Cell Panels, Article Number: LCT-TRAY-PI, Rev 14. BK840013. Catalog Identification: LCT1W30 (Lots 26, 27); LCT1W60 (Lots 26, 27); and LCT1W72 (Lots 3, 4). Article Number: LCT-TRAY-PI, Rev 14. Class II One Lambda, Inc., part of Thermo Fisher Scientific, is conducting a correction of Lambda Cell Tray", because the product insert for Lambda Cell Tray products (document identification LCT-TRAY-PI-EN-00, Rev 14), contains a documentation error. In the product insert, line 2 in the Directions For Use section is mistakenly repeated. The documentation error in the protocol may cause an end user to incorrectly perform a second incubation and wash off the product. This duplication may result in additional cell loss during the washing procedure. One Lambda Inc
Devices ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml. Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654. Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601. Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14. Class II HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers or other analyte values are affected. Horiba Instruments, Inc dba Horiba Medical
Devices Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD Class II Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. Carestream Health Inc.
Devices Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD Class II Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. Carestream Health Inc.
Devices Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems. Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769 Class II Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h) Medtronic Navigation, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients. 1000001310 1000601310 1230911309 1231211309 1231511309 1231811309 1000011310 1000311310 1000611310 1230921309 1231221309 1231521309 1231821309 1000021310 1000321310 1000621310 1230931309 1231231309 1231531309 1231831309 1000031310 1000331310 1000631310 1230941309 1231241309 1231541309 1231841309 1000041310 1000341310 1000641310 1230951309 1231251309 1231551309 1000051310 1000351310 1000651310 1230961309 1231261309 1231561309 1000061310 1000361310 1000661310 1230971309 1231271309 1231571309 1000071310 1000371310 1000671310 1230981309 1231281309 1231581309 1000081310 1000381310 1000681310 1230991309 1231291309 1231591309 1000091310 1000391310  ...
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Class II Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices Greatbatch Medical, Offset Cup Impactor. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). all lots Class I Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. Greatbatch Medical
Drugs Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16. Class II CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. Teva Pharmaceuticals USA
Drugs Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 Lot # 34017426A, Exp. 10/16. Class II CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. Teva Pharmaceuticals USA
Drugs Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02. Lot # 34017575A, Exp. 10/16. Class II CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. Teva Pharmaceuticals USA
Drugs Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02. Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16. Class II CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. Teva Pharmaceuticals USA
Devices Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation. Serial numbers of units distributed from October 16, 2012 to December 18, 2013: 189,190,191,192,193,207,208,209,210,211,212,213,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,235,236,237,238,244,245,246,247,248,249,264,265,266,267,268,269,270,271,272,273,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299. Class II Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER. MEDICAMAT S.A.
Devices GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module 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 medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM. Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G  ...
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Class II GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AVOA alarms will not automatically appear on the left side of the Solar display. In addition, the user interface menus on the discharged patient monitor will not function correctly. This may result in delayed treatment due to missed alarms that may be serious. GE Healthcare, LLC
Food Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206 Lot 1573, 1873, 1843 , 2073 (which was repackaged into 3253 and 3263), & 3273 Class I Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk. Deb-El Food Products, LLC.
Drugs Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3. Lot #: 151631, Exp 10/15 and 152767, Exp 11/15 Class III Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out. Aaron Industries Inc
Devices Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation. Product M320, Accessory Shorts with lot numbers XIN1212 and XIN0413. Class II Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient. AlterG, Incorporated
Devices Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650. Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807. Class II Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals. Focus Diagnostics Inc
Devices DeRoyal(R) ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries, 200 DeBusk Lane, Powell, TN 37849 lot numbers 33347799, 33444071, and 33423747 Class II Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely. DeRoyal Industries Inc
Devices Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. Part Number #180704-1, Lot #12151013-1. Class II The product may be mislabeled and could result in the incorrect implant being used. Mako Surgical Corporation
Devices PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2373868, 2397890, 2407867, 2410931, 2417878, 2417880 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2373869, 2375897, 2382870, 2397889, 2410932 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2383867, 2397883 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot # 2410919 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2367883, 2383868, 2397882, 2410914 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot # 2410918 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices MEDITECH Microbiology - Calculator/data processing module, for clinical use. Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13. Class II Potential for patient results being removed from LAB/EMR. Medical Information Technology, Inc.
Food Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each. 1106 Class I Positive Salmonella finding BIG RED TOMATO PACKERS, LLC
Devices FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip. Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packaged/labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa Class II Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (10 units)were not distributed. The units labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 on the outside and containing Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the inside (10 units) were distributed. Djo Surgical
Devices BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement. Part #1010-451 Lot #13121434 Class II As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary Cement Remover". Heraeus Kulzer, LLC.
Food Dark Meat Fajita School Lunch #3 88835 Dark Meat Fajita School Lunch, lot #'s 020401, 020402, 020403, 020404, 020405, 020406, 020407, 020408, 020409, 020410, 020411, 020412 (611 bags, manufactured on 1/20/14), and lot #'s 022401, 022402, 022403 (152 bags, manufactured on 1/22/14) Class I An ingredient used to manufacture the product tested positive for Salmonella Pepper Source Limited
Food Heart of the Valley brand Parsnips, produce of U.S.A., packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016; 20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes No lot codes used Class III Parsnips were found to be above tolerance, maximum residue level, for the pesticide linuron. Ed Fields & Sons, Inc
Cosmetics Wet Nuru Massage Gel, Nuru Original, Net Wt. 8.8 oz and 38 oz. Lot No. 25562 and 25674. Class II Due to microbial contamination Trigg Laboratories, Inc
Cosmetics Wet Nuru Massage Gel, Nuru Concentrate, Net Wt. 8.8 oz and 38 oz. Lot No. 25563, 25659, and 25672. Class II Due to microbial contamination Trigg Laboratories, Inc
Food 18 lb box of Curly Parsley packaged in 3 wire wooden crates Lot AG01GN Class I Sample of Parsley was found positive with Salmonella. Roth Farms Inc
Devices Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft. part no. 02.231.240, lot no. 823111 Class II Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). Synthes, Inc.
Drugs Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2. Lot #: 57617531, Exp 03/14 Class II Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Actavis Elizabeth LLC
Food Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 10984 2. Case UPC 84114 10982 5. Best By Date: 01MAY14. Case Manufacturing Code: 09309210 05:00 through 09309210 10:30 05:00 and 10:30 represent 5:00 am-10:30 am - production time stamp. Class I Kettle Foods, Inc. is recalling Bakes Sea Salt Potato Chips, Kettle Brand, due to potential undeclared milk. Diamond Foods Inc
Food Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton. Best By: 06/14/2015. UPC: 0-71580-08103-1. Class I This voluntary recall has been initiated because Dairy Rich Chocolate Ice Cream may contain peanut butter, which contains a peanut allergen. Ice Cream Specialities
Food Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile hummus GF 100% NATURAL** Exp. Dates 2/14,2014, 2/16, 2/21, 2/23, 2/28, 2/30, 3/3, 3/5, 3/10, 3/12,2014 Class I Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes. Falafel King Ent, Inc.
Food Falafel King Green Chili Hummus Wrap, 8.5 oz individual packages of the Green Chili Hummus Wraps Exp. Dates 2/14,2014, 2/16, 2/21, 2/23, 2/28, 2/30, 3/3, 3/5, 3/10, 3/12,2014 Class I Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes. Falafel King Ent, Inc.
Devices Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments. PFA14001,PFA14002,PFA14003,PFA14004,PFA14005,PFA14006,PFA14007,PFA14008,PFA14009,PFA14010,PFA14011,PFA14012,PFA14013,PFA14014,PFA14015,PFA14016,PFA14017,PFA14018,PFA14019,PFA14020,PFA14021,PFA14022,PFA14023,PFA14024,PFA14025,PFA14026,PFA14027,PFA14028,PFA14029,PFA14030,PFA14031,PFA14032,PFA14033,PFA14034,PFA14035,PFA14036,PFA14037,PFA14038,PFA14039,PFA14040,PFA14041,PFA14042,PFA14043,PFA14044,PFA14045,PFA14046,PFA14047,PFA14048,PFA14049,PFA14050,PFA14051,PFA14052,PFA14053,PFA14054,PFA14055,PFA14056,PFA14057,PFA14058,PFA14059,PFA14060,PFK13106,PFK13107,PFK13108,PFK13109,PFK13110,PFK13111,PFK13112,PFK13113,PFK13114,PFK13115,PFK13116,PFK13117,PFK13118,PFK13119,PFK13120,PFK13121,PFK13122,PFK13123,PFK13124,PFK13125,PFK13126,PFK13127,PFK13128,PFK13129,PFK13130,PFK13131,PFK13132,PFK13133,PFK13134,PFK13135,PFK13136,PFK13137,PFK13138,PFK13139,PFK13140,PFK13141,PFK13142,PFK13143,PFK13144,PFK13145,PFL13001,PFL13002,PFL13003,PFL13004,PFL13005,PFL13006,PFL13007,PFL13008,PFL13009,PFL13010,PFL13011,PFL13012,PFL13013,PFL13014,PFL13015,PFL13016,PFL13017,PFL13018,PFL13019,PFL13020,PFL13021,PFL13022,PFL13023,PFL13024,PFL13025,PFL13026,PFL13027,PFL13028,PFL13029,PFL13030,PFL13031,PFL13032,PFL13033,PFL13034,PFL13035,PFL13036,PFL13037,PFL13038,PFL13039,PFL13040,PFL13041,PFL13042,PFL13043,PFL13044,PFL13045,PFL13046,PFL13047,PFL13048,PFL13049,PFL13050, Class II WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction. WalkMed Infusion, LLC
Devices Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Model (s), Catelogue, or Code Numbers were identified as: 1040000 Trilogy 202 International, Number 1040005 Trilogy200 USA, 1054096 Trilogy 100 International, 1054260 Trilogy 100 USA, 1040004 Trilogy 02, and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447; TV114011448; TV114011449 TV11401144A; TV11401144B; TV11401144C; TV11401144D; TV11401144E; TV114011450; TV114011451; TV11401145B; TV11401145C; TV11401145D; TV11401145F; TV114011460; TV114011461; TV114011462;  ...
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Class I Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. Phillips Respironics, Inc.
Devices Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. Product Number: MIH-3333; NDC Number: 64253-333-33; Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15. Class III The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe). Medefil Incorporated
Drugs Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02 Lot 25-097-DK; Exp 01/01/2015 Class II Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. Hospira Inc.
Biologics Tendon 2643580002008; 2643590002008; 2643600002008; 2643610002008; 2643620002008; 2643630002008; 2643640002008; 2643650002008; 2643660002008; 2643670002008; Class II Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Drugs 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09 Lot 34-609-FW; Exp 10/15 Class II Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. Hospira Inc.
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