• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of April 30, 2014

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established. List Number: 06J37-018; Lot Number: 440023 Class III 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe. Abbott Molecular
Drugs JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle Manufacturing Codes: 10.06.2011 Exp. 09.06.2013 Class I Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Dolphin Intertrade Corporation
Drugs XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box All Lots Class I Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Dolphin Intertrade Corporation
Drugs RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309 Lots QL110408B046, QL110714A102 Exp. 11/13 Class I Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil. Fossil Fuel Products, LLC
Drugs Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045. Lot #: 10292013@15, Beyond Use Date: 11/28/2013 Class I Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis. Brookfield Prescription Center Inc
Cosmetics Obagi Medical C-Cleansing Gel, deeply Cleans to Remove Makeup and Excess Oil, 33.8 fl. oz. (1 L), Not for Retail Sale, Distributed by OMP, Inc., Long Breach, CA 90806 Lot No. 1304400-13B1017, UPC Code 362032070544 Class III Product was mislabeled as Obagi Medical Toner Valeant Pharmaceuticals North America LLC DBA Orapharma Inc.
Devices Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW 11215 and HW20001 to HW 20296. Class I The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. HeartWare Inc
Devices VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721. Class II Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC. Ortho-Clinical Diagnostics
Devices RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9. Class II RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image. RAYSEARCH LABORATORIES AB
Devices MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. model nos. 10746665, 10746666, 10847610, 10746700 Class II It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose, and could potentially crash down during an examination. Siemens Medical Solutions USA, Inc
Drugs Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant, extended release tablets, 10- count box, Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 UPC 0118223315555 Lot # 2554936, 2554938; Exp 09/15 Class II Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. Ohm Laboratories, Inc.
Devices Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. Lots 10251, 10201, 10301, 10401, 10481, 10381, 11041, 11321, 12151, 12231, 1226, 11201, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381 Class II Sterility of the product cannot be guaranteed. Teleflex Medical
Biologics Platelets Pheresis Leukocytes Reduced W050912000317 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. HCSC-Blood Center
Devices Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Class II Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). Ion Beam Applications S.A.
Drugs VPRIV® (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. US: Lot #: FEW13-001, FEW13-002, FED13-006; Expiry: 10/15. Mexico: Lot #: FED 013-010; Expiry: 10/15. Columbia: Lot #: FED 013-011; Expiry: 10/15. Class I Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. Shire Human Genetic Therapies, Inc.
Biologics Red Blood Cells Leukocytes Reduced W227712350683 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W227712350683 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W036513108377 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeShare Blood Centers
Devices LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers. Product List Number: 112410403; Lot Numbers: 280055H, 341005H Class II Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL. Hospira Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036513147804 Class III Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W2885103008452, W288314000067, W287914000029 Class II Blood products, which were incorrectly stored in a single storage bag, were distributed. LifeSource
Biologics Platelets Pheresis Leukocytes Reduced W287313002231, W288314000014 Class II Blood products, which were incorrectly stored in a single storage bag, were distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced W280313301085 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Upstate New York Transplant Services
Biologics Red Blood Cells Leukocytes Reduced W035213060977E Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets W035213060977E Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035213060977E Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W036213874696 Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed. Belle Bonfils Memorial Blood Center
Devices Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing. Part Number 0702-045-027 Class II During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the package of the product. Stryker Instruments Div. of Stryker Corporation
Biologics Plasma Frozen within 24 hours (FP24) W087613610841 Class II Blood products, collected from a donor who was taking the medication Propecia, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W087613610841 Class II Blood products, collected from a donor who was taking the medication Propecia, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W067113096468 Class III Blood product, labeled with the incorrect anticoagulant, was distributed. Blood Center Hammond Laboratory (the)
Biologics Red Blood Cells Leukocytes Reduced W201914018033 Class III Blood Product, prepared from an overweight unit, was distributed. American Red Cross Blood Services Tennessee Valley Region
Biologics Source Plasma AY0882006 Class III Source Plasma, collected from an ineligible donor, was distributed. Yale Blood Plasma LLC
Biologics Source Plasma TT0296070 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. DCI Biologicals Temple Terrace, LLC
Biologics Plasma Frozen W041613052132U; Class II Blood product, manufactured from an overweight whole blood unit, was distributed. Blood Systems, Inc. DBA United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W115913223046; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Central California Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W201713805168 Class II Blood product, in which quality control/distribution of product did not meet specifications. American National Red Cross (The) - North Central Region
Devices Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014 Class II A reagent contained within the product may return false negative results. Remel Inc
Devices Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014 Class II A reagent contained within the product may return false negative results. Remel Inc
Devices TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component. 00-6202-060-22; lot 62490588 Class II Three complaints were received in which it was noted intra-operatively that the shell was missing the locking ring. Zimmer, Inc.
Drugs Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01. Labeled A) 72 Ct Vial: Lot #13468 (exp 4/14), 13618 (exp 6/14) & 14105 (exp 2/15); 81 Ct- Vial, Lot #13815 (exp 10/14), 13864 (exp 11/14) & 13941 (exp 12/14); 108 Ct- Vial, Lot # 13574 (exp 7/14). Labeled B) 72 Ct Vial, Lot #13573 (exp 6/14) & 14257 (exp 7/15). Labeled C) 72 Ct Vial: Lot # 13875 (exp 5/14), 13642 (exp 7/14), 13770 (exp 8/14) & 13875 (exp 11/14). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01. Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07. Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07. Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial: Lot # 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp 11/14), 13867 (exp 11/14), 13897 (exp 12/14), 13960 (exp 1/15), 13981 (exp 12/14), 14016 (exp 2/15), 14254 (exp 7/15), 14305 (exp 7/15), 14341 (exp 7/15), 14370 (exp 8/15) & 14465 (exp 11/15). Labeled B) 72 Count Vial, Lot #13417 (exp 5/14), 13570 (exp 6/14), 13974 (exp 1/15), 14089 (exp 2/15), 14225 (exp 5/15), 14269 (exp 7/15), 14311 (exp 7/15) & 14396 (exp 8/15).Labeled C) 108 Ct Vial: Lot #:13656 (exp 8/14), 13753 (exp 9/14). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03. 81 Ct Vial, Lot # 13727 (exp 8/14), 13816 (exp 10/14), & 13965 (exp 12/14); 189 Ct Vial, Lot # 12H17N (exp 4/14), 12H20N (exp 6/14), 12J16N (exp 6/14), 12K03N (exp 9/14), 12L05N (exp 10/14), 12L07N (exp 9/14), 12L17N (exp 10/14), 13A04N (exp 11/14), 13A23N (exp 11/14), 13C04N (exp 1/15), 13C08N (exp 1/15), 13D17N (exp 11/14), 13D18N (exp 1/15), 13D18N1 (exp 3/15), 13E24N (exp 4/15), 13E28N (exp 4/15), 13G16N (exp 4/15), 13G17N (exp 5/14), 13H02N (exp 5/15), 13H22N (exp 5/15), 13I18N (exp 8/15), 13I20N (exp 5/15), 13J24N (exp 8/15), 13J24N1 (exp 9/15), 13K08N (exp 8/15), 13K11N (exp 9/15), 13L11N (exp 10/15) & 13L11N1 (exp 10/15). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03. 81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2. Lot #12K16W (exp 5/14), 12K27N (exp 6/14), 12K27W (exp 6/14), 12K29N (exp 6/14), 13K20W (exp 6/15), 13K20W1 (exp 6/15) & 13K25N (exp 6/15). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03. (20 ct) Lot #13444 (exp 05/14), 13486 (exp 06/14), 13547 (exp 06/14), 13619 (exp 06/14), 13675 (exp 07/14), 13833 (exp 11/14), 13921 (exp 11/14), 14008 (exp 1/15), 14150 (exp 4/15), 14195 (exp 4/15), 14260 (exp 7/15), 14286 (exp 7/15), 14379 (exp 9/15), 14428 (exp 9/15), 14463 (exp9/15) & 14507 (exp 10/15); (27 ct) Lot: 14190 (exp 5/15), 14383 (exp 9/15); (81 ct) Lot # 13374 (exp 4/14), 13392 (exp 4/14), 13445 (exp 5/14), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct) Lot #12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15). Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02. (20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15) Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Drugs Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2. Lot #13L05N, Expiry: 8/15 Class III Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Devices Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System. Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13 Class II The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. Pega Medical Inc.
Devices ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079 Class II Branan Medical is recalling the ToxCup Drug Screen Cup because they may be labeled with incorrect result interpretation graphics on the ToxCup lid label. Branan Medical Corporation
Devices ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. Codes - 1002706740, Exp. Date 10/14/2014, 1002717860, Exp. Date 10/24/2014, 1002742610, Exp. Date 10/30/2014, 1002760700, Exp. Date 11/4/2014, 1002821420, Exp. Date 11/26/2014, 1002857840, Exp. Date 12/12/2014, 1002860530, Exp. Date 12/12/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Devices FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, Exp. Date 8/15/2014, 1002792840, Exp. Date 8/15/2014, 1002834130, Exp. Date 8/22/2014, 1002877370, Exp. Date 8/22/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Devices API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. Code - 1002786740, Exp. Date 6/3/2014, 1002809140, Exp. Date 6/18/2014, 1002814890, Exp. Date 9/9/2014, 1002814891, Exp. Date 9/9/2014, 1002826750, Exp. Date 6/3/2014, 1002869720, Exp. Date 6/18/2014, 1002869721, Exp. Date 12/13/2014, 1002485910, Exp. Date 6/3/2014, 1002485911, Exp. Date 6/18/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Devices API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, Exp. Date 7/18/2014, 1002856800, Exp. Date 6/12/2014 Class II bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent BioMerieux SA
Biologics Red Blood Cells Leukocytes Reduced W270113513474 Class II Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W270113513482, W270113588339 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Central Pennsylvania Blood Bank
Biologics Platelets Pooled Leukocytes Reduced W270113587483 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W204014019129 Class III Blood product, for which the entire amount of additive solution was not added during manufacturing, was distributed. American Red Cross Blood Services Heart of America Region
Biologics Platelets Pheresis Leukocytes Reduced W043814300166; W043814300161; W043814300161; W043814300161; W043814300165; W043814300165; W043814300165; W043814320100; W043814320100; W043814320105; W043814320105; W043814320105; W043814320104; W043814320104 Class III Blood products, in which quality control testing was performed, interpreted, or documented incorrectly, were distributed. LifeShare Community Blood Services
Devices Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. lot #23F14A0375 Class II Arrow is recalling the Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet due to a labeling inconsistency. Arrow has received complaints for lot 23F14A0375 that kits are packaged with the incorrect catheter, specifically the kits contain a 40cm catheter and should contain a 50cm catheter. Arrow International Inc
Devices Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. lot RF2110924 Class II Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM Arrow International Inc
Biologics Red Blood Cells Leukocytes Reduced W035814018093 Class III Blood product, collected from a donor without documentation of a body temperature, was distributed. BloodSource, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051513043766- part 1; W051513043766-part 2 Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Platelets Pheresis Leukocytes Reduced W149514940848; W149514221179 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. Northern California Community Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W149514221269-part 1; W149514221269-part 2; W149514221269-part 3 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed Northern California Community Blood Bank
Devices Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 Units distributed from November 2006 through March 2014. Class II The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. Philips Medical Systems, Inc.
Devices Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1 Class II Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations Philips Medical Systems, Inc.
Drugs Tikosyn® (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60 H48496, H48497; Exp 05/15 Class II Presence of Foriegn Tablets/Capsules: A single Tikosyn® (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn® (dofetilide) 500 mcg (0.5 mg). Pfizer Inc.
Food Creative Snacks Co. Dried Apricots (10.5 oz Rigid Plastic Cup, and 7 oz Clear Plastic Bag), Distributed by: Creative Snacks, Co., Greensboro, NC 27409 Lot # - 2368112613 / Best Before: 07/24/2014; Lot # - 2406121313 / Best Before: 08/10/2014; Lot # - 2452010814 / Best Before: 09/5/2014; Lot # - 2481012114 / Best Before: 09/18/2014; Lot # - 7245123013 / Best Before: 07/28/2014. Class I Product contains undeclared allergen, Sulfites Creative Snacks Co., LLC
Devices Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5. Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number: 02F1101062; Product Code: EP4013P, Lot number: 02L0800898; Product Code: EP4110N, Lot number: 02H0900483; Product Code: X-2235, Lot numbers: 02E1102068, 02F1101041, 02F1201500, and 02G1201230; Product Code: X29-7271M2, Lot number: 02K1100784; Product Code: X-5667M8 and Product Code: X-6730M5, Lot number: 02G1300492. Class II The products are being recalled because they did not meet minimum diameter requirements. Teleflex Medical
Devices On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks. Model H08: Code numbers: H080002 H080065 H080126 H080187 H080251 H080314 H080378 H080441 H080503 H080607 H080672 H080749 H080944 H080003 H080066 H080127 H080188 H080252 H080315 H080379 H080442 H080504 H080608 H080673 H080753 H080947 H080004 H080068 H080128 H080189 H080254 H080316 H080380 H080443 H080506 H080609 H080674 H080754 H080948 HOSOOOS H080069 H080129 H080190 H0802SS H080317 H080381 H080444 H080507 H080610 H080675 H0807SS H080950 H080006 H080071 H080130 H080191 H080256 H080318 H080382 H080445 H080508 H080611 H080676 H080756 H080960 H080008 H080072 H080131 H080192 H080257 H080319 H080383 H080446 H080509 H080612 H080677 H080759 H080961 H080009 H080073 H080132 H080193 H080258 H080320 H080384 H080447 HOSOSlO H080613 H080678 H080760 H080962 H080010 H080074 H080133 H080194 H080259 H080321 H08038S H080448 H080511 H080614 H080679 H080761 H080969 H080011 H080075 H080134 H080195 H080260 H080322 H080386 H080449 HOSOS12 H080615 H080680 H080762 H080970 H080012 H080076 H080136 H080196 H080261 H080324 H080387 H080450 H080513 H080616 H080683 H080763 H080971 H080013 H080077 H080137 H080197 H080262 H080325 H080389 H080451 H080514 H080617 H080684 H080764 H080989 H080014 H080078 H080138 H080198 H080263 H080326 H080391 H080452 H08051S H080618 H080685 H080766 H080991 H080016 H080079 H080139 H080199 H080264 H080327 H080392 H080453 H080516 H080619 H080686 H080768 H080997 H080017 HOSOOSO H080141 H080200 H080266 H080328 H080393 H080454 H080517 H080620 H080687 H080772 H081001 H080018 HOSOOSl H080142 H080202 H080267 H080329 H080394 H080455 H080518 H080621 H080688 H080773 H081004 H080019 H080082 H080143 H080203 H080268 H080330 H080395 H080456 H080519 H080622 H080689 H080774 H081005 H080020 H080083 H080144 H080204 H080269 H080331 H080396 H080457 H080520 H080623 H080690 H080775 H081006 H080021 H080084 H080145 H080205 H080270 H080332 H080397 H080458 H080521 H080624 H080691 H080778 H081007 H080022 H080085 H080147 H080206 H080271 H080333 H080398 H080459 H080522 H080625 H080692 H080783 H081009 H080024 H080086 H080148 H080207 H080272 H080334 H080399 H080460 H080523 H080626 H080693 H080786 H081017 H08002S H080087 H080149 H080208 H080273 H080335 H080400 H080461 H080524 H080627 H080695 H080788 H081019 H080026 H080088 H080150 H080209 H080274 H080336 H080401 H080462 H080525 H080628 H080696 H080791 H081020 H080027 H080089 H080151 H080210 H080275 H080337 H080402 H080463 H080526 H080629 H080697 H080798 H081021 H080028 H080090 H080152 H080211 H080276 H080338 H080403 H080464 H080527 H080630 H080698 H080800 H081023 H080029 H080091 H080153 H080212 H080277 H080339 H080404 H080465 H080528 H080631 H080699 H080801 H08102S H080030 H080092 H080154 H080213 H080278 H080340 H080405 H080466 H080529 H080632 H080700 H080805 H081026 H080031 H080093 H080155 H080214 H080279 H080341 H080407 H080467 H080530 H080633 H080701 H080812 H081027 H080032 H080094 H080156 H080215 H080280 H080342 H080408 H080468 H080531 H080634 H080702 H080836 H081031 H080033 H080095 H080157 H080216 H080281 H080344 H080409 H080469 H080532 H080635 H080703 H080840 H081034 H080034 H080096 H080158 H080217 H080282 H080345 H080410 H080470 H080534 H080636 H080706 H080852 H081035 H080035 H080097 H080159 H080218 H080283 H080346 H080411 H080471 H080535 H080637 H080707 H080853 H081037 H080036 H080098 H080160 H080219 H080286 H080348 H080412 H080472 H080536 H080641 H080708 H080857 H081038 H080037 H080099 H080161 H080220 H080287 H080349 H080413 H080473 H080537 H080642 H080709 H080859 H081042 H080038 H080100 H080162 H080221 H080288 H080350 H080414 H080474 H080538 H080643 H080710 H080860 H081043 H080039 H080101 H080163 H080222 H080289 H080351 H080415 H080476 H080539 H080644 H080711 H080861 H081044 H080040 H080102 H080164 H080224 H080290 H080352 H080416 H080478 H080540 H080645 H080712 H080864 H081045 H080041 H080103 H080165 H080225 H080291 H080353 H080417 H080479 H080541 H080646 H080713 H080865 H081046 H080042 H080104 H080166 H080226 H080292 H080354 H080418 H080480 H080542 H080647 H080714 H080866 H081050 H080044 H080105 H080167 H080227 H080294 H080355 H080419 H080481 H080543 H080650 H080716 H080867 H081051 H080045 H080107 H080168 H080228 H080295 H080356 H080420 H080482 H080544 H080651 H080717 H080868 H081058 H080046 H080108 H080169 H080229 H080296 H080357 H080421 H080484 H080545 H080652 H080718 H080869 H081061 H080047 H080109 H080170 H080230 H080297 H080358 H080423 H080485 H080546 H080653 H080726 H080870 H081064 H080048 H080110 H080171 H080231 H080298 H080359 H080424 H080486 H080547 H080654 H080727 H080873 H081066 H080049 H080111 H080172 H080232 H080299 H080360 H080425 H080487 H080548 H080655 H080728 H080877 H081067 H080050 H080112 H080173 H080234 H080300 H080361 H080426 H080488 H080549 H080656 H080729 H080881 H081070 H080051 H080113 H080174 H080235 H080301 H080362 H080427 H080489 H080550 H080657 H080730 H080882 H081074 H080052 H080114 H080175 H080236 H080302 H080363 H080428 H080490 H080551 H080659 H080733 H080885 H081077 H080053 H080115 H080176 H080237 H080303 H080364 H080429 H080491 H080552 H080660 H080734 H080897 H081080 H080054 H080116 H080177 H080238 H080304 H080365 H080430 H080492 H080553 H080661 H080736 H080899 H081081 HOSOOSS H080117 H080178 H080239 H080305 H080366 H080431 H080493 H080554 H080662 H080738 H080903 H081087 H080056 H080118 H080179 H080240 H080306 H080368 H080432 H080494 HOSOSSS H080663 H080739 H080904 H081088 H080057 H080119 H080180 H080243 H080307 H080369 H080433 H080495 H080557 H080664 H080740 H080913 H081095 H080059 H080120 H080181 H080244 H080308 H080371 H080435 H080497 HOBOS58 H080665 H080741 H080924 H081096 H080060 H080121 H080182 H080245 H080309 H080373 H080436 H080498 H080601 H080666 H080742 H080929 H081100 H080061 H080122 H080183 H080246 H080310 H080374 H080437 H080499 H080602 H080667 H080745 H080930 H081105 H080062 H080123 H080184 H080247 H080311 H08037S H080438 HOSOSOO H080604 H080668 H080746 H080936 H081107 H080063 H080124 H080185 H080248 H080312 H080376 H080439 H080501 H080605 H080669 H080747 H080939 H081108 H080064 H080125 H080186 H0802SO H080313 H080377 H080440 H080502 H080606 H080670 H080748 H080943 H081109 H081110 H082044 H082106 H082171 H082234 H082298 H082363 H082490 H082553 H082619 H082684 H082749 H082813 H081112 H08204S H082107 H082172 H082235 H082299 H082364 H082491 H082SSS H082620 H082685 H082750 H082814 H08111S H082046 H082108 H082173 H082236 H082300 H082365 H082492 H0825S6 H082621 H082686 H082751 H082815 H081118 H082047 H082109 H082174 H082237 H082301 H082366 H082493 H082SS7 H082622 H082687 H082752 H082816 H081119 H082048 H082110 H08217S H082238 H082302 H082367 H082494 H082559 H082623 H082688 H082753 H082817 H081120 H082049 H082112 H082176 H082239 H082303 H082368 H082495 H082560 H082624 H082689 H082754 H082818 H081121 H082050 H082113 H082177 H082241 H082304 H082369 H082496 H082561 H08262S H082690 H082755 H082819 H081122 H082051 H082114 H082179 H082242 H082306 H082370 H082498 H082562 H082626 H082691 H082756 H082820 H08112S H082052 H08211S H082180 H082243 H082307 H082371 H082499 H082563 H082627 H082692 H082757 H082821 H081129 H082053 H082116 H082181 H082244 H082308 H082372 H082SOO H082564 H082628 H082693 H082758 H082822 H081130 H082054 H082117 H082182 H082245 H082309 H082373 H082501 H082565 H082629 H082694 H082759 H082823 H081131 H082055 H082118 H082183 H082246 H082310 H082374 H082502 H082566 H082630 H082695 H082760 H082824 H081132 H082056 H082119 H082184 H082247 H082311 H082375 H082503 H082567 H082631 H082696 H082761 H082825 H081141 H0820S7 H082120 H08218S H082248 H082312 H082376 H082504 H082568 H082632 H082697 H082762 H082826 H081143 H0820S8 H082121 H082186 H082249 H082313 H082377 H082505 H082569 H082633 H082698 H082763 H082827 H081146 H082059 H082122 H082187 H082250 H082314 H082378 H082506 H082570 H082634 H082699 H082764 H082828 H081147 H082060 H082123 H082188 H082251 H082315 H082379 H082507 H082571 H082635 H082700 H082765 H082829 H081148 H082061 H082124 H082189 H082252 H082316 H082380 H082508 H082572 H082636 H082701 H082766 H082830 H081149 H082062 H082125 H082190 H082253 H082317 H082381 H082509 H082573 H082637 H082702 H082767 H082831 H081150 H082063 H082126 H082191 H082254 H082318 H082382 H082510 H082574 H082638 H082703 H082768 H082832 H081153 H082064 H082127 H082192 H082255 H082319 H082383 H082511 H082575 H082639 H082704 H082769 H082833 H0811SS H08206S H082128 H082193 H082256 H082320 H082384 H082512 H082576 H082640 H08270S H082770 H082834 H081160 H082066 H082129 H082194 H082257 H082321 H082385 H082513 H082578 H082641 H082706 H082771 H08283S H082000 H082067 H082130 H08219S H082258 H082322 H082386 H082514 H082579 H082642 H082707 H082772 H082836 H082001 H082068 H082131 H082196 H082259 H082323 H082387 H082515 H082580 H082643 H082708 H082773 H082837 H082002 H082069 H082133 H082197 H082260 H082324 H082388 H082516 H082581 H082644 H082709 H082774 H082838 H082003 H082070 H082134 H082198 H082261 H08232S H082389 H082517 H082582 H08264S H082710 H082776 H082839 H082004 H082071 H08213S H082199 H082262 H082326 H082390 H082518 H082583 H082646 H082711 H082777 H082840 H08200S H082072 H082136 H082200 H082263 H082327 H082391 H082519 H082584 H082647 H082712 H082778 H082841 H082006 H082073 H082137 H082201 H082264 H082328 H082392 H082520 H082SBS H082649 H082713 H082779 H082842 H082007 H082074 H082138 H082202 H08226S H082330 H082393 H082521 H082586 H0826SO H082714 H082780 H082843 H082008 H082075 H082139 H082203 H082266 H082331 H082394 H082522 H082587 H082651 H08271S H082781 H082844 H082009 H082076 H082140 H082204 H082267 H082332 H082395 H082523 H082588 H082652 H082716 H082782 H082845 H082010 H082077 H082141 H082205 H082268 H082333 H082396 H082524 H082589 HOB2653 H082717 H082783 H082846 H082011 H082078 H082142 H082206 H082269 H082334 H082397 H082525 H082590 H082654 H082718 H082784 H082847 H082012 H082079 H082143 H082207 H082270 H082335 H082398 H082526 H082591 H082655 H082719 H082785 H082848 H082013 H082080 H082144 H082208 H082271 H082336 H082399 H082527 H082592 H082656 H082720 H082786 H082849 H082014 H082081 H082145 H082209 H082272 H082337 H082400 H082528 H082593 H082657 H082721 H082787 H082850 H082015 H082082 H082146 H082210 H082273 H082338 H082401 H082529 H082594 H082658 H082722 H082788 H082851 H082016 H082083 H082147 H082211 H082274 H082339 H082402 H082530 H082595 H082659 H082723 H082789 H082852 H082017 H082084 H082148 H082212 H082275 H082340 H082403 H082531 H082596 H082660 H082724 H082790 H082853 H082018 H082085 H082149 H082213 H082276 H082341 H082404 H082532 H082597 H082661 H082725 H082791 H082854 H082020 H082086 H082150 H082214 H082277 H082342 H082406 H082533 H082598 H082662 H082726 H082792 H082855 H082021 H082087 H082151 H082215 H082278 H082343 H082407 H082534 H082599 H082663 H082727 H082794 H082856 H082022 H082088 H082152 H082216 H082279 H082344 H082408 H082535 H082600 H082664 H082730 H082795 H082857 H082023 H082089 H082153 H082217 H082280 H082346 H082409 H082536 H082601 H082666 H082731 H082796 H082858 H082024 H082090 H082154 H082218 H082282 H082347 H082410 H082537 H082602 H082667 H082732 H082797 H082859 H082025 H082091 H082156 H082219 H082283 H082348 H082411 H082538 H082603 H082668 H082733 H082798 H082860 H082026 H082092 H082157 H082220 H082284 H082349 H082412 H082539 H082604 H082669 H082734 H082799 H082861 H082031 H082093 H082158 H082221 H082285 H082350 H082450 H082540 H082605 H082670 H082735 H082800 H082862 H082032 H082094 H082159 H082222 H082286 H082351 H082451 H082541 H082606 H082671 H082736 H082801 H082864 H082033 H082095 H082160 H082223 H082287 H082352 H082452 H082542 H082607 H082672 H082737 H082802 H082865 H082034 H082096 H082161 H082224 H082288 H082353 H082453 H082543 H082608 H082673 H082738 H082803 H082866 H082035 H082097 H082162 H082225 H082289 H082354 H08247S H082544 H082609 H082674 H082739 H082804 H082868 H082036 H082098 H082163 H082226 H082290 H082355 H082476 H082545 H082610 H082675 H082740 H082805 H082869 H082037 H082099 H082164 H082227 H082291 H082356 H082480 H082546 H082611 H082676 H082741 H082806 H082870 H082038 H082100 H082165 H082228 H082292 H082357 H082482 H082547 H082613 H082678 H082743 H082807 H082871 H082039 H082101 H082166 H082229 H082293 H082358 H082484 H082548 H082614 H082679 H082744 H082808 H082872 H082040 H082102 H082167 H082230 H082294 H082359 H082485 H082549 H082615 H082680 H082745 H082809 H082873 H082041 H082103 H082168 H082231 H082295 H082360 H082487 H082550 H082616 H082681 H082746 H082810 H082874 H082042 H082104 H082169 H082232 H082296 H082361 H082488 H082551 H082617 H082682 H082747 H082811 H082875 H082043 H082105 H082170 H082233 H082297 H082362 H082489 H082552 H082618 H082683 H082748 H082812 H082876 H082877 H082944 H083010 H083074 H083144 H083210 H083274 H083343 H083406 H083474 H083536 H083603 H083667 H082878 H082945 H083011 H083075 H083145 H083211 H083275 H083344 H083407 H083475 H083537 H083604 H083668 H082879 H082946 H083012 H083076 H083146 H083212 H083276 H083345 H083408 H083476 H083539 H083605 H083669 H082880 H082947 H083013 H083077 H083147 H083213 H083277 H083346 H083409 H083477 H083540 H083606 H083670 H082881 H082948 H083014 H083078 H083148 H083214 H083279 H083347 H083410 H083478 H083541 H083607 H083671 H082882 H082949 H083015 H083079 H083149 H083215 H083280 H083348 H083412 H083479 H083543 H083608 H083672 H082883 H082950 H083016 H083080 H083150 H083216 H083281 H083349 H083413 H083480 H083544 H083609 H083673 H082884 H082951 H083017 H083082 H083152 H083217 H083282 H083350 H083414 H083481 H083546 H083610 H083674 H082885 H082952 H083018 H083083 H083153 H083218 H083283 H083351 H083415 H083482 H083547 H083611 H083676 H082886 H082953 H083019 H083084 H083154 H083219 H083284 H083352 H083416 H083483 H083548 H083612 H083677 H082887 H082954 H083020 H083085 H083155 H083220 H083285 H083353 H083417 H083484 H083549 H083613 H083678 H082888 H0829SS H083021 H083086 H083156 H083221 H083287 H083354 H083418 H083485 H083550 H083614 H083679 H082889 H082957 H083022 H083087 H083157 H083222 H083288 H083355 H083419 H083486 H083551 H08361S H083680 H082890 H082958 H083023 H083088 H083158 H083224 H083289 H083356 H083420 H083487 H083552 H083616 H083681 H082891 H082959 H083024 H083089 H083159 H083225 H083290 H083357 H083421 H083488 H083553 H083617 H083682 H082892 H082960 H08302S H083090 H083160 H083226 H083291 H083358 H083422 H083489 H083SS4 H083618 H083683 H082893 H082961 H083026 H083091 H083161 H083227 H083292 H083359 H083423 H083490 H083556 H083619 H083684 H082894 H082962 H083027 H083092 H083162 H083228 H083293 H083360 H083424 H083491 H083557 H083620 H08368S H08289S H082963 H083029 H083093 H083163 H083229 H083294 H083361 H083425 H083492 H083558 H083621 H083686 H082896 H082964 H083030 H083094 H083164 H083230 H083295 H083363 H083426 H083493 H083559 H083622 H083687 H082897 H08296S H083031 H08309S H083165 H083231 H083297 H083364 H083427 H083494 H083560 H083623 H083688 H082898 H082966 H083033 H083096 H083166 H083232 H083298 H083365 H083428 H083495 H083561 H083624 H083689 H082899 H082967 H083034 H083098 H083167 H083233 H083299 H083366 H083429 H083496 H083562 H08362S H083690 H082900 H082968 H08303S H083103 H083168 H083234 H083300 H083367 H083430 H083497 H083563 H083626 H083691 H082901 H082969 H083036 H083104 H083169 H083235 H083301 H083368 H083433 H083498 H083564 H083627 H083692 H082902 H082970 H083037 H083105 H083170 H083236 H083302 H083369 H083434 H083499 H083565 H083628 H083693 H082903 H082971 H083038 H083106 H083171 H083237 H083303 H083370 H083436 H083500 H083566 H083629 H083694 H082904 H082972 H083039 H083107 H083172 H083238 H083304 H083371 H083437 H083501 H083567 H083630 H083695 H082905 H082973 H083040 H083108 H083173 H083239 H083306 H083372 H083438 H083502 H083568 H083631 H083696 H082907 H082974 H083041 H083109 H083174 H083241 H083308 H083373 H083439 H083503 H083569 H083632 H083697 H082910 H082975 H083042 H083110 H083175 H083242 H083309 H083374 H083440 H083504 H083570 H083633 H083698 H082911 H082976 H083043 H083111 H083176 H083243 H083310 H083375 H083441 H083SOS H083571 H083634 H083699 H082912 H082977 H083044 H083112 H083177 H083244 H083311 H083376 H083442 H083506 H083572 H083635 H083700 H082913 H082978 H083045 H083113 H083178 H083245 H083312 H083377 H083443 H083507 H083573 H083636 H083701 H082914 H082979 H083046 H083114 H083179 H083246 H083313 H083378 H083444 H083508 H083574 H083637 H083702 H082915 H082980 H083047 H083115 H083180 H083247 H083314 H083379 H083445 H083509 H083575 H083638 H083703 H082916 H082981 H083048 H083116 H083181 H083248 H083315 H083380 H083446 H083510 H083576 H083639 H083704 H082917 H082982 H083049 H083117 H083182 H083249 H083316 H083381 H083447 H083511 H083577 H083640 H083705 H082919 H082983 H083050 H083119 H083183 H083250 H083317 H083382 H083448 H083512 H083578 H083642 H083706 H082920 H082984 H083051 H083120 H083184 H083251 H083318 H083383 H083449 H083513 H083579 H083643 H083707 H082921 H082985 H083052 H083121 H083185 H083252 H083319 H083384 H083450 H083514 H083580 H083644 H083708 H082922 H082986 H083053 H083122 H083186 H083253 H083321 H083385 H083451 H083515 H083581 H083645 H083709 H082923 H082987 H083054 H083123 H083187 H083254 H083322 H083386 H083452 H083516 H083582 H083646 H083710 H082924 H082988 H0830SS H083124 H083188 H0832SS H083323 H083387 H083453 H083517 H083583 H083647 H083711 H082925 H082990 H083056 H083125 H083189 H083256 H083324 H083388 H083454 H083518 H083584 H083648 H083712 H082926 H082991 H083057 H083126 H083190 H083257 H083325 H083389 H0834SS H083519 H083585 H083649 H083713 H082927 H082993 H083058 H083127 H083191 H083258 H083326 H083390 H083456 H083520 H083586 H083650 H083714 H082928 H082994 H083059 H083128 H083192 H083259 H083327 H083391 H083457 H083521 H083587 H083651 H083715 H082929 H082995 H083060 H083129 H083193 H083260 H083328 H083392 H083458 H083522 H083588 H083652 H083716 H082930 H082996 H083061 H083130 H083194 H083261 H083330 H083393 H083459 H083523 H083590 H083653 H083717 H082931 H082997 H083062 H083131 H083195 H083262 H083331 H083394 H083461 H083524 H083591 H083654 H083718 H082932 H082998 H083063 H083132 H083196 H083263 H083332 H083395 H083462 H083525 H083592 H0836SS H083720 H082933 H082999 H083064 H083133 H083197 H083264 H083333 H083396 H083463 H083526 H083593 H083657 H083721 H082934 H083000 H083065 H083135 H083198 H083265 H083334 H083397 H083464 H083527 H083594 H083658 H083722 H082935 H083001 H083066 H083136 H083199 H083266 H083335 H083398 H083465 H083528 H083595 H083659 H083724 H082937 H083002 H083067 H083137 H083200 H083267 H083336 H083399 H083466 H083529 H083596 H083660 H083725 H082938 H083003 H083068 H083138 H083202 H083268 H083337 H083400 H083467 H083530 H083597 H083661 H083726 H082939 H08300S H083069 H083139 H083204 H083269 H083338 H083401 H083468 H083531 H083598 H083662 H083727 H082940 H083006 H083070 H083140 H083205 H083270 H083339 H083402 H083469 H083532 H083599 H083663 H083728 H082941 H083007 H083071 H083141 H083206 H083271 H083340 H083403 H083470 H083533 H083600 H083664 H083729 H082942 H083008 H083072 H083142 H083207 H083272 H083341 H083404 H083471 H083534 H083601 H083665 H083730 H082943 H083009 H083073 H083143 H083208 H083273 H083342 H083405 H083473 H083535 H083602 H083666 H083731 H083732 H083794 H083960 H084027 H084092 H083740 H083802 H083970 H084035 H083748 H083810 H083979 H084043 H083733 H083795 H083961 H084028 H084093 H083741 H083803 H083971 H084036 H083749 H083811 H083980 H084044 H083734 H083796 H083963 H084029 H084094 H083742 H083804 H083972 H084037 H083750 H083812 H083981 H084045 H083735 H083797 H083964 H084030 H08409S H083743 H08380S H083973 H084038 H083751 H083813 H083982 H084046 H083736 H083798 H083965 H084031 H084096 H083744 H083806 H083974 H084039 H083752 H083814 H083983 H084047 H083737 H083799 H083967 H084032 H084097 H083745 H083807 H083976 H084040 H083753 H083815 H083984 H084048 H083738 H083800 H083968 H084033 H084098 H083746 H083808 H083977 H084041 H083754 H083816 H083985 H084049 H083739 H083801 H083969 H084034 H084099 H083747 H083809 H083978 H084042 H083755 H083817 H083986 H084050 H083756 H083818 H083987 H084051 H083764 H083827 H083996 H084060 H083772 H083837 H084004 H084068 H083786 H083757 H083819 H083988 H084052 H083765 H083830 H083997 H084061 H083773 H083839 H084005 H084070 H083787 H083758 H083820 H083990 H084054 H083766 H083831 H083998 H084062 H083774 H083883 H084006 H084071 H083788 H083759 H083821 H083991 H084055 H083767 H083832 H083999 H084063 H083775 H083885 H084007 H084072 H083789 H083760 H083822 H083992 H084056 H083768 H083833 H084000 H084064 H083776 H083941 H084008 H084073 H083790 H083761 H083823 H083993 H084057 H083769 H083834 H084001 H084065 H083777 H083943 H084010 H084074 H083791 H083762 H083824 H083994 H084058 H083770 H08383S H084002 H084066 H083778 H083944 H084011 H084075 H083792 H083763 H083825 H083995 H084059 H083771 H083836 H084003 H084067 H083779 H083945 H084012 H084076 H083793 H083780 H083946 H084013 H084077 H083781 H083947 H084014 H084078 H083782 H083948 H084015 H084079 H083956 H083783 H083949 H084016 H084080 H083784 H083950 H084017 H084081 H083785 H083951 H084018 H084082 H083957 H083952 H084019 H084084 H083953 H084020 H084085 H083954 H084021 H084086 H083955 H084022 H084087 H083958 H084023 H084088 H084024 H084089 H084025 H084090 H083959 H084026 H084091. Class II Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning. Varian Medical Systems, Inc.
Devices GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. Mfg Lot or Serial # System ID 0000000VE90667 VE9000667 0000000VE90680 VE9000680 0000000VE90878 VE9000878 0000000VE91045 VE9001045 0000000VE91821 VE9001821 0000000VE91826 VE9R001826 0000000VE92470 VE9R002470 0000000VE93780 VE9R003780 0000000VE94119 VE9R004119 0000000VE94120 VE9R004120 0000000VE94291 VE9R004291 0000000VE94521 VE9004521 0000000VE94736 VE9R004736 0000000VE94790 VE9R004790 0000000VE94876 VE9R004876 0000000VE95024 VE9R005024 0000000VE95025 VE9R005025 0000000VE95027 VE9R005027 0000000VE95028 VE9R005028 0000000VE95222 VE9R005222 0000000VE95226 VE9R005226 0000000VE95271 VE9R005271 0000000VE95302 VE9R005302 0000000VE95319 VE9R005319 0000000VE95558 VE9R005558 0000000VE95597 VE9R005597 0000000VE95599 VE9R005599 0000000VE95604 VE9R005604X 0000000VE95654 VE9005654 0000000VE95908 VE9005908 0000000VE95949 VE9005949 0000000VE95960 VE9005960 0000000VE95969 VE9005969 0000000VE96001 VE9006001 0000000VE96004 VE9006004 0000000VE96005 VE9006005 0000000VE96008 VE9006008 0000000VE96009 VE9006009 0000000VE96010 VE9006010 0000000VE96020 VE9006020 0000000VE96022 VE9006022 0000000VE96138 0000000VE96185 VE9006185 0000000VE96186 VE9006186 0000000VE96187 VE9006187 0000000VE96188 VE9006188 0000000VE96189 VE9006189 0000000VE96190 VE9006190 0000000VE96191 VE9006191 0000000VE96193 VE9006193 0000000VE96194 VE9006194 0000000VE96210 VE9006210 0000000VE96211 VE9006211 0000000VE96212 VE9006212 0000000VE96232 VE9006232 0000000VE96233 VE9006233 0000000VE96234 VE9006234 0000000VE96235 VE9006235 0000000VE96281 VE9006281 0000000VE96282 VE9006282 0000000VE96310 VE9006310 0000000VE96312 VE9006312 0000000VE96357 VE9006357 0000000VE96359 VE9006359 0000000VE96360 VE9006360 0000000VE96361 VE9006361 0000000VE96474 VE9006474 0000000VE96475 VE9006475 0000000VE96477 VE9006477 0000000VE96566 VE9006566 0000000VE96567 VE9006567 0000000VE96568 VE9006568 0000000VE96569 VE9006569 0000000VE96570 VE9006570 0000000VE96571 VE9006571 0000000VE96657 VE9006657 0000000VE96678 VE9006678 0000000VE96685 VE9006685 0000000VE96786 VE9006786 0000000VE96790 VE9006790 0000000VE96791 VE9006791 0000000VE96081 AE1405US16 0000000VE90720 911367109 0000000VE90721 911367111 0000000VE92490 0911363976A 0000000VE92575 911369282 0000000VE94465 529150US29 0000000VE96149 83099254441 0000000VE96336 83099717941 0000000VE96337 83100013639 0000000VE96338 83100014025 0000000VE96339 83100014713 0000000VE96343 83100014763 0000000VE96344 83100014862 0000000VE96345 83100014782 0000000VE96365 83100997529 0000000VE96366 83100079792 0000000VE96367 83100997315 0000000VE92794 AH4307US35 0000000VE95988 DEMOUS0118 0000000VE96082 DEMOUS0123 0000000VE96507 AH5846US26 0000000VE96509 AH4001US79 0000000VE96517 AH5846US27 0000000VE96554 AH5099US07 0000000VE96578 AH5293US14 0000000VE96579 AH5689US32 0000000VE96635 AH5402US03 0000000VE91731 110093US12 0000000VE91878 220078US29 0000000VE95567 030232US22 0000000VE96327 210001US36 0000000VE96823 110093US18 0000000VE90343 VE9VE90343 0000000VE96809 CZ4015US27 0000000VE96810 CZ4015US28 0000000VE96811 CZ4015US29 0000000VE96812 CZ4015US30 0000000VE96843 CZ4015US31 0000000VE90568 DK1058US25 0000000VE91152 DK1079US06 0000000VE91759 DK1058US26 0000000VE92228 DK1009US16 0000000VE92422 DK1085US07 0000000VE92624 DK1018US23 0000000VE93555 DK1108US17 0000000VE93557 DK1058US27 0000000VE93558 DK1086US05 0000000VE94067 DK1029US32 0000000VE94068 DK1029US31 0000000VE94069 DK1029US33 0000000VE94286 DK1018US27 0000000VE94547 DK1083US48 0000000VE94548 DK5005US13 0000000VE95783 DK1204US09 0000000VE96056 DK1058US31 0000000VE96057 DK1058US32 0000000VE96334 DK1087US15 0000000VE96577 DK1083US59 0000000VE96668 DK1009US20 0000000VE96691 DK1000US25 0000000VE96692 DK1085US10 0000000VE96709 DK1079US22 0000000VE96710 DK1079US23 0000000VE96711 DK1079US24 0000000VE96712 DK1018US28 0000000VE96763 DK1029US37 0000000VE93238 FI1003US41 0000000VE95053 FI1003US60 0000000VE95929 FI1387US45 0000000VE96453 FI1034US11 0000000VE96462 FI1000US43 0000000VE96643 FI1025US25 0000000VE96944 FI1008US05 0000000VE91314 US73018013 0000000VE91824 USM9319104 0000000VE91879 USM9483807 0000000VE92151 U257035001 0000000VE92876 U172259004 0000000VE92895 USM2376712 0000000VE93593 USM4400108 0000000VE94549 USM4202407 0000000VE94550 US20005505 0000000VE94598 U191660607 0000000VE94599 U191660608 0000000VE94600 U191660609 0000000VE94684 UM41470601 0000000VE95034 U178486402 0000000VE95181 U304151801 0000000VE95182 U304151802 0000000VE95370 U289468803 0000000VE95451 US78113506 0000000VE95495 U224933302 0000000VE95620 US78034309 0000000VE95648 US55001908 0000000VE96037 USM4400115 0000000VE96096 US67500903 0000000VE96180 U217921402 0000000VE96223 US25000605 0000000VE96236 US55554116 0000000VE96237 USM4501713 0000000VE96240 U276410803 0000000VE96398 USM1464505 0000000VE96440 U235798703 0000000VE96441 US63001301 0000000VE96624 USM4024501 0000000VE96660 US25971506 0000000VE96661 US78027123 0000000VE96735 U202809302 0000000VE96744 U347517301 0000000VE96745 U304151808 0000000VE96746 U304151809 0000000VE96747 U235798704 0000000VE96934 U230344704 0000000VE96935 U230344705 0000000VE91368 145763U004 0000000VE91496 1280997U05 0000000VE92722 112093U006 0000000VE93136 110783U036 0000000VE93992 1280997U06 0000000VE94294 102014U003 0000000VE94585 148119U004 0000000VE95506 149657U047 0000000VE95971 110783U038 0000000VE95972 110783U039 0000000VE95973 110783U040 0000000VE95974 110783U041 0000000VE95975 110783U049 0000000VE95976 110783U046 0000000VE95977 110783U052 0000000VE96197 110395U003 0000000VE96239 122019U154 0000000VE96386 110016U020 0000000VE96387 110277U002 0000000VE96388 1280997U08 0000000VE96410 145769U013 0000000VE96411 2264533U02 0000000VE96412 110052U022 0000000VE96413 112032U009 0000000VE96414 144523U006 0000000VE96422 1882626U21 0000000VE96423 1937574U17 0000000VE96424 145100U030 0000000VE96425 3475651U01 0000000VE96483 122109U071 0000000VE96726 1685347U18 0000000VE96728 109045U026 0000000VE96729 389839U003 0000000VE96737 105827U369 0000000VE96738 105827U370 0000000VE96739 389502U011 0000000VE96740 113467U005 0000000VE96741 103302U055 0000000VE96970 TP2467U001 0000000VE92175 1519325087 0000000VE92409 1500666946 0000000VE94499 1975347812 0000000VE94500 00033ULT10 0000000VE95209 00192ULT35 0000000VE95658 143030209 0000000VE96017 172863842 0000000VE96026 124383452 0000000VE96029 172863846 0000000VE96030 172863850 0000000VE96031 172863854 0000000VE96238 1942347245 0000000VE96417 131842062 0000000VE96418 142787282 0000000VE96446 113363002 0000000VE96447 194674632 0000000VE96461 152033592 0000000VE96465 113587062 0000000VE96576 186696112 0000000VE96593 175744912 0000000VE96594 175744924 0000000VE96609 128549752 0000000VE96610 103660948 0000000VE96612 114391312 0000000VE96613 114391316 0000000VE96626 131680572 0000000VE96639 128549772 0000000VE96640 139515512 0000000VE96641 114392062 0000000VE96650 1942347598 0000000VE96695 103535162 0000000VE96730 1942555904 0000000VE96731 1793709237 0000000VE96840 IE1560US14 0000000VE96893 156706072 0000000VE96913 174072702 0000000VE93278 83038829010513 0000000VE95537 83038829553713 0000000VE96557 83037001070513 0000000VE96611 IE1199US03 0000000VE91149 A5320150 0000000VE91360 A5672210 0000000VE96331 A5174260 0000000VE96527 A5529128 0000000VE90202 UY9007 0000000VE90260 UY9016 0000000VE90621 UY9060 0000000VE90645 UY9057 0000000VE90646 UY9056 0000000VE90722 UY9070 0000000VE90725 UY9066 0000000VE90726 UY9067 0000000VE91230 UY9116 0000000VE91591 UY9134 0000000VE91610 UY9136 0000000VE92296 UY9186 0000000VE93638 UYA278 0000000VE93641 UYA281 0000000VE93656 UYA276 0000000VE93966 UYA297 0000000VE93984 UYA303 0000000VE93985 UYA300 0000000VE94031 UY9301 0000000VE94032 UY9302 0000000VE94449 UY9332 0000000VE94530 UYA340 0000000VE94663 UY9343 0000000VE94761 UY9356 0000000VE94767 UYZ354 0000000VE94988 UY9380 0000000VE95011 UY9387 0000000VE95014 UY9390 0000000VE95472 UY9411 0000000VE95521 UY9412 0000000VE95522 UY9415 0000000VE95523 UY9417 0000000VE95524 UY9418 0000000VE95525 UY9419 0000000VE95527 UYA423 0000000VE95580 UY9422 0000000VE95737 UY9426 0000000VE95832 UY9434 0000000VE95861 UY9448 0000000VE95863 UY9431 0000000VE95887 UY9440 0000000VE95897 UY9445 0000000VE95898 UY9447 0000000VE95899 UY9449 0000000VE96134 UY9450 0000000VE96135 UY9456 0000000VE96136 UY9457 0000000VE96137 UY9458 0000000VE96139 UY9473 0000000VE96164 UY9466 0000000VE96165 UY9476 0000000VE96166 UY9471 0000000VE96167 UY9482 0000000VE96168 UY9477 0000000VE96201 UY9479 0000000VE96202 UY9467 0000000VE96203 UY9468 0000000VE96204 UY9469 0000000VE96205 UY9470 0000000VE96246 UY9453 0000000VE96247 UY9459 0000000VE96248 UY9474 0000000VE96249 UY9454 0000000VE96252 UY9455 0000000VE96253 UY9460 0000000VE96262 UY9461 0000000VE96288 UY9464 0000000VE96289 UY9472 0000000VE96290 UY9462 0000000VE96291 UY9465 0000000VE96292 UY9490 0000000VE96293 UY9493 0000000VE96373 UY9491 0000000VE96380 UY9475 0000000VE96466 UY9483 0000000VE96467 UY9496 0000000VE96468 UY9484 0000000VE96469 UY9478 0000000VE96470 UY9485 0000000VE96471 UY9497 0000000VE96558 UY9486 0000000VE96559 UY9487 0000000VE96605 UY9495 0000000VE96606 UY9488 0000000VE96607 UY9492 0000000VE96608 UY9489 0000000VE96779 UY9501 0000000VE96780 UY9502 0000000VE96781 UY9503 0000000VE96783 UY9505 0000000VE96784 UY9506 0000000VE96785 UY9507 0000000VE96829 UY9508 0000000VE96830 UY9509 0000000VE96832 UY9521 0000000VE96858 UY9512 0000000VE96859 UY9511 0000000VE96860 UY9510 0000000VE96861 UY9513 0000000VE96862 UY9518 0000000VE96890 UY9519 0000000VE96907 UY9522 0000000VE96917 UY9516 0000000VE96919 UY9517 0000000VE96920 UY9520 0000000VE94450 850370200 0000000VE96297 HDW02402 0000000VE92970 920369512 0000000VE90124 NO4153US04 0000000VE90447 NO4146US07 0000000VE91393 NO4011US82 0000000VE92941 NO4070US26 0000000VE94749 NO4016US63 0000000VE94750 NO4016US62 0000000VE95151 NO4011U136 0000000VE95293 NO4000US33 0000000VE95608 NO5005US42 0000000VE96195 NO4064US16 0000000VE96209 NO4013US04 0000000VE96217 NO4088US43 0000000VE96218 NO4088US44 0000000VE96335 NO4088US46 0000000VE96399 NO4155US04 0000000VE96644 NO4068US72 0000000VE96707 NO4068US73 0000000VE96755 NO4071US08 0000000VE96756 NO4110US09 0000000VE96714 PL3169US01 0000000VE95268 PER28513 0000000VE96757 PER43240 0000000VE96828 PER02553 0000000VE96931 PES16600 0000000VE96169 RU8488US01 0000000VE96216 6073UL0050 0000000VE96911 ZA2561US23 0000000VE96200 UE255934 0000000VE94024 R002US41 0000000VE95588 M047US02 0000000VE96058 FA50US57 0000000VE96627 N004US10 0000000VE96767 A022US36 0000000VE96844 G002US07 0000000VE96845 G002US06 0000000VE96847 G001US18 0000000VE90483 534551US01 0000000VE90547 547150US03 0000000VE91374 529170US09 0000000VE91375 830593US03 0000000VE92013 475200US24 0000000VE92038 720050US05 0000000VE92226 748253US01 0000000VE93801 482896US03 0000000VE94437 260010US31 0000000VE94660 475200US31 0000000VE95592 900010US68 0000000VE95738 266210US04 0000000VE95896 529050US19 0000000VE95927 260010US36 0000000VE96048 124057US01 0000000VE96151 103000US06 0000000VE96332 850020US31 0000000VE96333 529230US13 0000000VE96439 707220US05 0000000VE96672 850010US07 0000000VE96702 506463US03 0000000VE96808 534551US02 0000000VE96815 527356US02 0000000VE94534 853380306 Class II GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat. GE Healthcare, LLC
Devices GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. FMI 60865 (DV Family Gradient Connections) Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296070MR6 253596GHTMR 00001307FMM05K 256881MR1 00001301FMM04T 256HHMR2 00000296840MR2 256HICMR2 00000302944MR4 256ODCMR1 00000303639MR9 260426VAMR 00000301255MR6 260920MR 00000302633MR3 262656MR1 00000301867MR8 262687MR1 00000308096MR7 262785mr1 00000295802MR3 269DVMR 00000000UA0138 270798MR2 00000294057MR5 281274MR1 00000000UA0028 281274MR2 00000290050MR4 281276MR750 00000298727MR9 281348450WMR 00000296429MR4 281364MR2 00001001BD6325 281477MR2 00000304177MR9 301295MR3T2 00000295215MR8 301295MR4 00001106XF5046 301295MR5 00000301518MR7 301295MR6 00000000UA0027 3014643TMR 00000300687MR1 301496MR3T4 00001301FMM047 301570MR 00000000HM0570 301618MR2 00001234FMM0J4 302993MR 00000298675MR0 303278MR 00000000HM0583 303338MR1 00000000HM0591 303338MR2 00000303940MR1 303426MR 00000304578MR8 303427MRW 00000303646MR4 303444MR 00000000UA0029 303604MR2 00000299213MR9 303699MR2 00000294494MR0 304256MR2 00000302631MR7 304766MR4 00000302248MR0 305243MR1 00001245FMM03P 305284MR1 00000000UA0085 305461MR1 00000304493MR0 305854MR1 00000301046MR9 308398HDMR 00001301FMM04G 309344MR450W 00000296469MR0 309662JMR450W 00000305101MR8 309672MR450W 00000296046MR6 309683MNMR750 00000305519MR1 310289MR 00000303805MR6 312355DVMR 00000301924MR7 312996MR3T 00000299952MR2 313593MR450 00000000UA0091 314577CGMR3T 00000301262MR2 315SOS450W 00000305521MR7 315SOSNORTH 00000303342MR0 316685MR 00001250FMM036 317338MR5 00000298399MR7 317865MR3 00000301519MR5 317887MR2 00000301190MR5 318769MR 00000299522MR3 319268MR 00000304355MR1 321FCMR1 00001301FMM045 330263450W 00000000UA0116 330344MR750W 00000300847MR1 330363450W 00000305176MR0 330489MR450W 00000000UA0144 337289MR1 00000000UA0074 337943MR1 00000029854MR5 352867MR 00000300987MR5 360507450WCM 00000298512MR5 360582450WPA 00000000UA0056 386FHPCMR3T 00000296908MR7 386FMR3T 00000302570MR7 402228MR 00000301013MR9 404329MR 00000000UA0034 405271OUCMR 00000299491MR1 405359EMR 00000302712MR5 405486MR 00000293561MR7 405752I3T 00000304151MR4 405912MMR 00001219FMM0GV 406375HMR 00000299141MR2 406543MR450W 00000305668MR6 407PMCMR 00000000UA0068 407SMSLMR1 00000000UA0083 408356MR1 00000302916MR2 412372MR1 00000299967MR0 412623MR1 00000300564MR2 412623SDHYMR3 00000298677MR6 412647PUHMR1 00000300494MR2 412647PUHMR2 00000298960MR6 412835MR1 00000306066MR2 412942MR2 00001307FMM01X 413568MR 00000000UA0167 414647MR1 00000298889MR7 414649WB3 00000298552MR1 414805MR1 00000298591MR9 414805MR2 00000300122MR9 414805MR4 00000297624MR9 415493VMR2 00000290202MR1 415723CHMR2 00000305165MR3 415723CHMR3 00000000HM0584 415723CHMR4 00000301295MR2 415723SCHMR2 00000291489MR3 415723SHMR10 00000000UA0057 415723SHMR12 00000000UA0064 415723SHMRW 00000000UA0073 415CB3TW 00000291877MR9 415L3TMR1 00000290773MR1 415L3TMR2 00000293261MR4 415OI3TMR 00000297877MR3 417COXMR1 00000302634MR1 417STJ450 00000303356MR0 417STJ4502 00000300704MR4 419407MR1 00000304799MR0 419893MR 00001307FMM019 419ARROWMR 00001301FMM03M 419PERRYMR 00001308FMM04V 419PRODEF 00000298932MR5 419WYMR 00000300906MR5 423553MR450 00000305617MR3 423844MR1 00000298908MR5 425111SMRW 00000299520MR7 425222SMRW 00000299823MR5 425450PMR 00000300713MR5 425688MR 00000299908MR4 425750PMR 00000300588MR1 434799MR1 00000301044MR4 434MJMR1 00000293646MR6 434UVAMR 00000000UA0089 435251MR1 00000297833MR6 435716MR1 00000302571MR5 441MR450 00000303375MR0 469820BMWMR1 00000305524MR1 479452450W 00000298861MR6 479757NW450 00000000HM0679 479964450W 00000298981MR2 480425MR6 00000294665MR5 480768MR2 00000301522MR9 484503MR 00000300473MR6 501202MR1 00000305102MR6 501221LEGACY450 00000304262MR9 501225450W1 00000306028MR2 501225450W2 00000302998MR0 501661VA450 00000000HM0618 502624MR2 00000303994MR8 503220MR1 00001213FMM0LF 504842MR2 00000299851MR6 505609MR 00000300967MR7 508548MR 00000300565MR9 508693MVMR 00000304851MR9 509332MR450W 00000299321MR0 509473DMR3T 00001236FMM01X 509482450W 00000298870MR7 509546MR450W 00000000HM0629 509837MR450W 00000000HM0461 509TCOMR450W 00000307611MR4 510449MR450W 00000301926MR2 510537MR750 00000306095MR1 512816SAMR 00000302545MR9 512LRMCMR 00000305982MR1 513732MR 00000306029MR0 513CCHGTMR 00001236FMM021 513MWMR1 00001106XF509C 515263MR450 00000296171MR2 515358MR1 00000296888MR1 515643MR450 00000000HM0529 516HSSMR 00000291397MR8 517353DVMR 00000298083MR7 517450W 00000030154MR0 517HILLMR 000005148810-3 518561MR 00000296841MRO 518563MRI 00000304440MR1 518579MR 00000306027MR4 520ACPMR2 00000301380MR2 520SMICMR 00000300764MR8 530876MR450 00000294556MR6 540665MR3T 00000299966MR2 540MIF3T750 00001250FMM020 541276MR450W 00000305667MR8 541317MR 00000292431MR4 541CMRIMR 00000297134MR9 541SAGHMR 0000000UA0001A 559734VIMR1 00000304494MR8 561747MR2 00000300900MR8 561795MR2 0000000UA0090A 561844MR1 00000298580MR2 570271MR6 00000296626MR5 573556MR450 00000305820MR3 573556MRW2 00000304763MR6 573756MAMR 00000296096MR1 573884MRI 00000301028MR7 574267MR 00000303812MR2 574335MR 00000305426MR9 574546MR 00000301401MR6 575622MRW1 00000305520MR9 580548BWB 00000000UA0071 585275MR750W 00000304508MR5 585785MR750 00000304720MR6 601354MR450W 00000300038MR7 601450W 00000304017MR7 601932MR450W 00000296462MR5 602588MR2 00000294576MR4 602830MR3 00001201FMM08B 602839MR1 00000000UA0096 6033343TW 00000295228MR1 6036503T 00000304719MR8 605322MR 00000303050MR9 605725MR 00000302688MR7 607CORNELL3T 00000299266MR7 608263MR4I 00000000UA0157 608263MR5W 00000290457MR1 608263MR6 00000296418MR7 608287MR1 00001052XF5031 608374MR 00000000HM0606 608775MR1 00000000UA0159 608775MR3T 00000307535MR5 608CHILDMR1 00000290957MR0 608HERIMR 00000288408MR8 608WAISMR 00000292528MR7 608WIMRMR2 00000299172MR7 609407MR 00000290659MR2 610740MR3 00000305910MR2 610997MRW 00000303645MR6 614257MR2 00000302194MR6 614566MR1 00000000UA0038 61456MR5 00000000UA0041 614GMC3T 00000303041MR8 614RMHMR3 00000303310MR7 615327MR450 00000296517MR6 615MTMR1 00000298420MR1 6162673T750 00000000UA0117 616267IMRI 00000298334MR4 616267MR450 00000298907MR7 616391450W 00000291363MR0 616391DVMR 00000298283MR3 616494DVMR 00000301469MR3 616774MR450W 00000000UA0030 616774MR750W 00000296640MR6 617726MR1A2 00000305451MR7 618288DVMR 00000298050MR6 618288OWMR 00000299645MR2 618997VAMR 00000000UA0075 619543HDMR4 00000306094MR4 623524MR1 00000300572MR5 630933MR3 00000000HM0484 630946MR1 00000299627MR0 631723MR450 00000305203MR2 631726MR450 00001301FMM03G 631968MR 00000303690MR2 636933JMR1 00000290137MR9 650723NCMR1 00000289309MR7 650723NCMR2 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000297374MR1 650PH3T 000000290605MR5 661KRMR750 00000305484MR8 662841MR5 00000000UA0147 671FHPMR750W 00000299264MR2 678565MR2 00000000HM0345 6970K 00000295134MR1 702616RDLMR 00000300968MR5 703205MR2 00000303773MR6 703205MR3 00000295111MR9 703391MR2 00000301599MR7 703573MR2DV 00000000UA0124 703698MR4 00000299683MR3 703805MR2 00000299544MR7 703805MR3 00000299181MR8 703858MR3T 00000304439MR3 704304DVMR 00000291980MR1 704384DVMR 00000304293MR4 704384MR450 00000305047MR3 704984DVMR 00000296829MR5 704CMCLMCMR 00000000HM0518 707521MR450W 00000303856MR9 707546MR450W 00000305485MR5 707651KVMR 00000300792MR9 707DG3T 00000000UA0050 708346MR3 00000000HM0708 713441MR6W 00000296114MR2 713441MR8 00000294398MR3 713441MR9 00000302796MR8 713566SMITH1 00000303439MR4 713566SMITH2 00000304167MR0 713566SMITH3 00001301FMM040 713792AMR13 00000299406MR9 713792CMR1 00000303614MR2 715623MRW 00000294718MR2 715838MR3T 00000300866MR1 715ADCMR1 00000306011MR8 716665MR1 00000296602MR6 7168453T 00000000HM0522 717975MR2 00000000UA0012 71872MR750W 00000299199MR0 719260MR 00000299331MR9 720321MR 00001250FMM02C 720708MR 00000302193MR8 720SAHMOBMR 00000304721MR4 724981MR450W 00000298574MR5 727462MR1 00000301126MR9 727834MR 00001251FMM00Y 731541MROP2 00000304319MR7 731644MR2 00000296860MR0 732249MR 00000302997MR2 732938MR 00001245FMM04T 7347633TMRFIX 00000000HM0612 757261mr 00000299200MR6 757312MR 00000000UA0099 757827MR2 00000294953MR5 7579533T 00000000HM0683 757953450WMR 00000000UA0141 757983MR 00000303767MR8 760452MR1 00000308080MR1 765362MR1 00001234FMM0J0 765448MR450 00000304168MR8 770252MR 00000299160MR2 770918GEMR 00000302434MR6 773525MR3 00000000HM0314 773792MRI 00000300985MR9 775SIERRAMR 00000297355MR0 775WNKAMR 00000296097MR9 781340MR2 00000300724MR2 781340MR3 00000304944MR2 781HV450MR 00000303777MR7 785623MR2 00000301869MR4 801262MR3 00000303778MR5 801268MR2 00000295112MR7 801377MR3 00000301228MR3 801475MR1 00000304852MR7 801535MR1 00000299294MR9 802371MR 00000304375MR9 803329DVMR 00000298722MR0 803434MR2 00000295092MR1 803434MRI 00000303637MR3 803751MR 00000304406MR2 804330MR450W 00000301379MR4 804WAT450 00000300732MR5 805687MR1 00001301FMM04Y 805898MR 00000305412MR9 805SCMR 0000000UA0032A 808485MR2 00000000UA0086 808545MR 00001251FMM01U 808873MR750W 00001227FMM00M 808HRAWMR 00001250FMM035 808YMMR 00000297974MR8 810235DVMR 00000298901MR0 810762MR 00000305522MR5 812265MR 00000294698MR6 812485MR3 00000300929MR7 813745MR2 00000306065MR4 814234MR450W 00000000HM0600 814237MR450W 00000304374MR2 814333MR450W 00000303855MR1 815215MR 00000300795MR2 815300MR1 00000000UA0048 815395MR2 00001251FMM03A 815399MR2 00000301156MR6 815664MR450W 00000301235MR8 815937MR 00000299559MR5 815971MR2 00000000HM0609 816276MRW 00000301378MR6 816561MRW 00000299515MR7 816698CP3T 00000296014MR4 816932DVMR 00000296040MR9 817321RATCMR1 00000304850MR1 817472TSMR1 00000299634MR6 817482BKMR1 00000303415MR4 818790MR1 00001118FMM0WD 828213MRW 00001101XF50B7 828213RMRW 00001106XF5016 828456MRW 00000301094MR9 828586MRW 00000298537MR2 832522MR1 00000300039MR5 832522MR2 00001236FMM01B 843390MR 00000296226MR0 843606MPMR 00001236FMM01W 843762CCMR 00001301FMM03V 843832SMR 00000298655MR2 845348MR 00001026XF5198 845368MRW 00001102XF506B 845454MR 00000300883MR6 845483MR 00000301198MR8 845794MRW 00000301260MR6 845943MR 00001012BD66BC 847618MR1 00001236FMM01F 847872ZMR1 00000000UA0139 847872ZMR2 00000299339MR2 847SAMCMR3 00001301FMM04E 850862MR1 00001250FMM023 850RA450W1 00001233FMM06X 856247MR1 00000304827MR9 856247MR2 00000000UA0092 856247MR3 00000000UA0146 856581MR3T 00000000HM0631 856768MR 00000305452MR5 858549HDMR1 00000000UA0118 858622HDMR1 00000950BD627C 858822HDMR1 00000301752MR2 858822HDMR2 00000944BD6172 858939MR3 00001106XF50A6 858939MR4 00001051XF5039 859301MR 00001102XF502F 859744MR450 00000304801MR4 860678450W 00000298248MR6 860749MR 00000301962MR7 863688MR 00000298310MR4 864225DVMR 00001050XF5015 864255SFMR 00001232FMM01T 864560DVMR 00001101XF50B8 864725MRI 00001049XF5011 864849DVMR 00000303692MR8 865525MR2 00000000HM0636 901384MR450 00000303765MR2 901726MR450 00000919BD5B82 903525MR750 00000305464MR0 903927MR450 00001106XF50C0 904202MR10 00000298387MR2 904202MR6 00001026XF5178 904202MR7 00000304124MR1 904202MR8 00000304536MR6 904202MR9 00001106XF50CB 904215MR11 00001049XF5008 906786WB 00001250FMM03D 9075653T 00000299230MR3 907729ANMR 00000304829MR5 907IAPMR1 00000303926MR0 908277MR1 00000298656MR0 908851MR 00001052XF5053 910323VRIMR 00000293015MR4 910907WAMR1 00000304717MR2 910CHMR450W 00001301FMM04X 912576MR 00000308068MR6 912819MR 00001106XF500D 913397DICOMRW 00000298765MR9 9155693TMR 00001101XF50BC 916961450MR 00000296512MR7 916LST3TMR 00000301424MR8 916MCCMR 00000297387MR3 916SUTROSMR 00000306030MR8 918286MR 00001027XF500C 918307MR 00001213FMM0LG 918333JPMR1 00001307FMM049 918333JPMR2 00000293065MR9 918491MR1 00000299161MR0 918523MR450 00000303693MR6 918599MR 00001301FMM04K 918744SJMR1 00000306131MR4 918744SJMR2 00000000HM0595 918893TCIMR 00000304836MR0 919684BIAC6 00000301292MR9 919684CC450W1 00000903BD55CC 919684MR5 00000304138MR1 919954RMR2 00000303813MR0 919JM450W 00000299411MR9 920288MR750 00000294280MR3 920830MR450 00000302748MR9 920885MR2 00000000UA0031 928348MR 00000305431MR9 937208MR2 00001251FMM018 937WHMR 00001213FMM0LE 952456MR450 00000302914MR7 952831MR3 00000301027MR9 952993MR1 00000303823MR9 954346MR1 00000297469MR9 954772MR1 00000304016MR9 956350MRW 00000000HM0624 970874MR 00000303664MR7 970945450W 00000306098MR5 971310MR1 00000302517MR8 973579MR 00000298869MR9 973971MR2 00000304765MR1 978287MR 00000297891MR4 985ONCMR 00000304943MR4 985SAMR 00000298834MR3 ALLIANCEOPT01 00000300793MR7 BMDACCMR1 00000000UA0128 BOSTONMEDMR1 00001251FMM01F BRIGHAM750WMR1 00000300723MR4 BRUNSWICKMR 00000302492MR4 CORT450W 00000304367MR6 DOA450W 00000296821MR2 DUPONT3T 00000000UA0069 EAST750W 00000298247MR8 FITZMR 00000302690MR3 HCIMR1805 00000299320MR2 HERITAGEMR 00000298181MR9 HSS75MR450 00000294643MR2 HSSFMR450 00000293874MR4 HSSGMR750 00000300590MR7 HSSHMR450W 00000302945MR1 HSSIMR450W 00000289310MR5 HSSMR750 00000292367MR0 INSIGHTMR3228 00000296573MR9 INSIGHTMR3231 00000298959MR8 INSIGHTMR3244 00000298573MR7 JHN450W 00000300722MR6 JOI610450W 00000305175MR2 LMCPMR 00000301866MR0 MAIN450W 00000300493MR4 MKMG450W 00000290502MR4 MR129030 00000290636MR0 MR129034 00000288907MR9 MR129035 00000294913MR9 MR129036 00000296461MR7 MR129037 00000302192MR0 MR229040 00000303616MR7 MR229042 00000303691MR0 MR229043 00000303665MR4 MR229044 00001219FMM0GT MR229045 00000000UA0150 MR229046 0000000UA0067A MR229047 00000291185MR7 MSK65MR1 00000291244MR2 MSK65MR2 00000296595MR2 MSK65MR3 00000294999MR8 MSK68MR4 00000296228MR0 MSK68MR5 00001301FMM04A OPTIMA02 00000300296MR1 ORMCMR1 00000297147MR1 PENNMEDMR 00001307FMM01V PHILLYNAVYMR 00000299503MR3 QUEEN450WMR 00000298943MR2 RADNETMR1588 00000298738MR6 RADNETMR1593 00000299173MR5 RADNETMR1594 00000301470MR1 RADNETMR1603 00000000HM0278 RADNETMR1604 00000297880MR7 RADNETMR1614 0000000UA0011A RADNETMR1629 00000000UA0060 RADNETMR1631 00000000UA0053 RADNETMR1632 00000000UA0066 RADNETMR1635 00000000UA0115 RADNETMR1639XX 00000000UA0062 RADNETMR1648 00000000HM0593 RADNETMR1650 00000000UA0149 RADNETMR1651 00000000UA0158 RADNETMR1652 00000300765MR5 RADNETMR593 00000000UA0046 RADNETMR597 00000000UA0055 RADNETMR598 00000000UA0065 RADNETMR599 00000289961MR5 SINAI750MR 00000303435MR2 SINAI8MR450W 00000303430MR3 SINAI9MR450W 00000300571MR7 SLMVMR450 00000298386MR4 SMSUSS3 00000298114MR0 SPRUCE450W 00000297493MR9 STCHRISMR 00000301308MR3 STLUKESOPTMR 00000308110MR6 801IMCMR4 0000000UA0101B 702382MR750W 00000301821MR5 UCDACCMR450 00000301597MR1 UM750MR 00000000UA0166 VAWESTROX750W 00000298494MR6 VINTAGE450 00000308112MR2 703689MR 00000308069MR4 COR526967 00000306801MR2 864529MR 00000308154MR4 406293MR450W 00000000HM0715 850431450W 00001308FMM05W 510784MR450W 00000298474MR8 302744MR750 00000000HM0731 856794MR 00001245FMM040 212543MR750 00000000HM0740 614663MR 00000000HM0714 316962MR450 00000000HM0503 RADNETMR1655 00000000UA0217 415CBMRP 0000000UA0111B 713798MR1 00000000HM0753 SMSVMS4 00000000HM0757 559325CIIMR3 00000000HM0748 432333MR 00000000HM0767 803313DVMR 00000000HM0742 METHODISTMR450W 00000000HM0666 713798MR2 00000000HM0720 972863WHWMR1 00000000UA0209 671NAVYMR 00000000UA0238 2148203TMR 00000000HM0735 503732MR1 0000000UA0132B 513636MR4 00000000HM0769 918744SJMR3 00000000UA0239 602863MR 0000000HM0566A CTCA450WGEMS 00000000HM0777 601968MR450W1 00000000HM0759 205783450W 00000000HM0773 732450WMR 00000000HM0763 702616MR450W 00000000HM0750 614HMOBMR 00000000HM0758 740454MR 00001250FMM03B 609267MR 00000000HM0594 610831450W 00000000HM0745 702PKWYMR 00000000HM0765 208678MR 00000000HM0770 405270VMR2 00000000HM0775 908859MR 00000000HM0779 NNHMR450W 00000000HM0781 319272MR 00000000HM0783 630352MRI 00000000HM0791 334418450W 00000000UA0231 913322MISHMRW 00000000UA0242 MR229048 00000000UA0253 317865MR4 00000304076MR3 209491SSMR 00001309FMM023 804CHI450W 0000000HM0702A 651968MR450W 00000000HM0539 240480MR 00000000HM0620 RADNETMR610 00000000HM0682 7493 00000000HM0734 708346MR6 00000000HM0739 510784MR450WSIL 00000000HM0749 708346MR5 00000000HM0760 7688 00000000HM0771 217528MR2 00000000HM0782 520STMMR 00000000HM0792 513870MR1 00000000HM0801 WMED450W 00000000HM0802 414778MR1 00000000HM0804 717791MR1 00000000HM0806 706845MR 00000000HM0808 803434DVMR 00000000HM0814 785239MR450 00000000UA0218 708346MR4 00000000UA0233 718226MR3T 00000000UA0234 510449MR750W 00000000UA0237 720854MR 00000000UA0244 937641MR2 00000000UA0252 763795MR1 00000000UA0260 207MMC3TMR 00000000UA0261 843815750W 00000000UA0262 949760MR3 00000000UA0264 715847MR3T 00000297637MR1 650723PSYMR 00000303927MR8 202715MR2 00000308791MR3 415MB3T 00001105XF503F ASLW750 00000000HM0744 334287MR 00000000HM0829 815395MR3 00000000HM0830 RADNETMR1660 00000000HM0832 315922MR 00000000HM0833 325670ICMR 00000000HM0835 704403DVMR 00000000UA0269 954355MR750W 00000308346MR6 MSK68MR7 00000308347MR4 MSK68MR6 00000308357MR3 650780MR750 00000308534MR7 00000308591MR7 00000308749MR1 00000308899MR4 00000308903MR4 00000309079MR2 00001251FMM01J DZ1006MR01 00000000HM0495 DZ1101MR01 00001227FMM012 DZ1011MR01 00000306373MR2 DZ1525MR01 00000305909MR4 MRHM0560 00000000UA0136 MRUA0136 00000000HM0559 MRHM0559 00000308180MR9 MRHM0774 00000000HM0670 00001308FMM01X 00000905BD566D 910272064 00001007BD646D 910272071 00001011BD633E 910272072 00003052527MR7 910272078 00000000HM0355 910272085 00001106XF50FF 910272091 00000305463MR2 910272093 00001203FMM0VW 910273043 00000291429MR9 910274032 00001117FMM0C7 910274039 00001134FMM10P 910274040 00001203FMM0W0 910274041 00001106XF50E8 910274042 00001102XF509F 910275008 00001204FMM044 910275009 00000000HM0710 83096322871 00000000HM0605 83090346059 00000000UA0248 83096536248 00000000UA0189 83092403928 00000000UA0226 83096535911 00000000HM0772 83096537610 0000000UA0121A 83104203907 00000000HM0837 83107577438 00001011BD663A 2867211 00000000UA0270 00000309051MR1 00001236FMM052 00001309FMM057 00000299229MR5 AH5824MR01 00000000UA0258 AH4300MR01 00000000HM0815 AZ4029MR01 00000300587MR3 BH1037MR01 00000301158MR2 BY4033MR01 00000000UA0047 BY4160MR01 00000294451MR0 030020MR03 00000000UA0093 140024MR01 00000000HM0729 210036MR02 00000000UA0268 130083MR05 00000000UA0251 220078MR01 00000297898MR9 2875893 00000297156MR2 2879385 00000298115MR7 2884624 00000295060MR8 MR13905YR5 00000300472MR8 MRHM0145 00000300586MR5 MRHM0158 00000300848MR9 MRHM0177 00000300474MR4 MRHM0208 00000301230MR9 MRHM0228 00000301197MR0 MRHM0264 00000299824MR3 MRHM0266 00000301584MR9 MRHM0267 00000301502MR1 MRHM0269 00000302203MR5 MRHM0323 00000303048MR3 MRHM0342 00000304353MR6 MRHM0350A 00000302990MR7 MRHM0358 00000302572MR3 MRHM0409 00000303939MR3 MRHM0430 00000304438MR5 MRHM0448 00000305403MR8 MRHM0523 00000306982MR0 MRHM0649 00000298251MR0 MRWB0558 00000000UA0184 MRUA0184 00000307449MR9 MRHM0711 00001301FMM03E MRUA0122 00000000HM0704 MR307144MR6 00000308509MR9 00000309092MR5 00001308FMM04D 00000000HM0712 MRHM0712 00000309092MR5 MRUA0272 00000294601MR0 250727MR2 00000000UA0042 403229MR1 00000300297MR9 403382MR1 00000294119MR3 403541MR1 00000300037MR9 403670MR1 00000299547MR0 403944MR1 00000295023MR6 403955MR1 00000000HM0507 416212MR450 00000291008MR1 416486MR3T 00000303049MR1 416486MR4 00000296265MR2 416595MR1 00000300986MR7 450466MR1 00000306026MR6 506544MR1 00000305624MR9 506623MR1 00000305413MR7 506648MR3 00000304471MR6 506739MR1 00000304351MR0 506857MR2 00000000HM0514 514262MR1 00000299686MR6 514281MR450 00000298951MR5 514345BMR1 00000030090MR1 514697MR450 00000300711MR9 514848MR1 00000299628MR8 519685MR2 00000291154MR3 519685MR3T 00000297850MR0 604582MR450 00000303327MR1 604875MR750 00000303821MR3 613721MR1 00000000UA0010 613737MR1 00000304945MR9 613938MR1 00000298717MR0 780532MR1 00000304855MR0 902893MR1 00000300563MR4 905522MR3T 00001002BD6387 905527MR1 00000307053MR9 306344MR1 00000000HM0694 403777MR1 00000000HM0701 403777MR2 00000000HM0726 905522MR2, 00000307803MR7 905522MR2 00000306911MR9 MR102094WH0 00001250FMM02U 00000297408MR7 CLCMR1 00001246FMM03C 82427120107 00000305164MR6 82427260003 00001245FMM03W 82427130071 00001245FMM04R 82427100202 00001106XF50D7 82427010056 00001101XF5019 82427020036 00000303964MR1 82427020039 00001106XF50C5 82427020042 00001106XF5055 82427040116 00000298116MR5 82427040119 00000301927MR0 82427040120 00001101XF5022 82427040121 00001101XF5016 82427040123 00001106XF5043 82427040127 00001106XF50DF 82427040132 00001106XF50B4 82427050028 00001101XF5035 82427070075 00001106XF508E 82427070079 00001106XF502D 82427090148 00001106XF504D 82427090169 00001101XF5027 82427100147 00001106XF507A 82427100149 00001106XF5125 82427120092 00001106XF512A 82427120097 00001101XF5033 82427130057 00001044XF5030 82427140074 00001106XF50C3 82427140076 00001106XF50D0 82427140087 00000300766MR3 82427150038 00001105XF502F 82427160088 00001026XF518E 82427180022 00001009BD65A1 82427210068 00001048XF500F 82427210091 00001003BD643B 82427230048 00000300963MR6 82427230051 00000302245MR6 82427230055 00000304175MR3 82427030076 00001106XF5104 82427100184 00001106XF50B6 82427270037 00001245FMM03L 82427010072 00001302FMM053 82427010073 00000000UA0200 82427120110 00000000UA0168 82427040135 00001106XF507B 82427060042 00000000UA0171 82427210109 00000306732MR9 82427040133 00000303871MR8 82427050029 00000303971MR6 82427150047 00000305117MR4 82427210081 00000305466MR5 82427040143 00000307506MR6 82427050033 00000307616MR3 82427040141 00001106XF508B 82427040128 00001302FMM04A 82427040114 00000307111MR5 82427040142 0000000UA0199A 82427040146 0000000UA0199A 82427040148 00000306612MR3 82427040153 00000306734MR5 82427140094 00000307507MR4 82427140098 00000307451MR5 82427150058 00000306731MR1 82427310057 00000307585MR0 82427310059 00000307131MR3 82427310062 00000308161MR9 82427090202 00000308162MR7 82427040137 00000308163MR5 82427120101 00000308207MR0 82427200058 00000308210MR4 82427160114 00000308358MR1 82427210116 00000308848MR1 82427040154 00000305814MR6 82427210118 00000308885MR3 82427160118 00000000UA0245 00000308885MR3 00001147FMM0EB 00001221FMM06R 00001236FMM00U 00001236FMM01N 00001301FMM03C 00001307FMM08G 00000308359MR9 82427130072 00000300966MR9 HR4199MR01 00000298847MR5 600110MR01 00000297813MR8 CS1006MR04 00000305405MR3 CS1338MR02 00000304800MR6 DK1001MR02 00000304373MR4 DK1044MR01 00000294548MR3 DK1083MR06 00000296291MR8 EG1000MR03 00000295827MR0 EG1793MR01 00000000HM0663 EG1024MR02 00001234FMM0K3 EE1012MR01 00000294713MR3 EE1019MR02 00000301912MR2 FI1015MR04 00000295485MR7 FI1052MR01 00000304492MR2 FI1052MR02 00000298431MR8 FI1120MR01 00000294397MR5 FI1128MR01 00000299453MR1 FI1149MR01 00000304580MR4 FI1175MR01 00000301520MR3 A1588529 00000296032MR6 A2032112 00000299464MR8 A4167338 00000296332MR0 A4171551 00001301FMM03H A4199398 00000296227MR2 B4498422 00000304295MR9 C2195281 00001221FMM06L C2195285 00000304538MR2 C4200438 00000302711MR7 F1680824 00000297164MR6 F4171505 00000296879MR0 M1279737 00000303376MR8 M1460210 00000301523MR7 M1656629 00000304123MR3 M171587016 00000293919MR7 M206565701 00001251FMM019 M2148250 00000000HM0634 M22006303 00000297715MR5 M226407301 00001140FMM0FV M2265406 00000298567MR9 M23084310 00000000UA0077 M2322246 00001301FMM03K M2322250 00000299341MR8 M24070301 00000301774MR6 M2427737 00000301291MR1 M24313801 00000120FMM0VC M24481307 00000297636MR3 M2634906 00000297494MR7 M2634909 00001301FMM04U M2737110 00000298242MR9 M28027100 00000305616MR5 M2848438 00000298073MR8 M2850008 00000298734MR5 M2950010 00000296141MR5 M40180117 00000294575MR6 M40330108 00001251FMM01H M40345203 00000303414MR7 M4040080 00000304077MR1 M4134645 00000292844MR8 M4152248 00000000000018 M4155416 00000298430MR0 M4159241 00000301868MR6 M4161643 00000000UA0019 M4166994 00000304555MR6 M4174545 00000295847MR8 M4182438 00000304718MR0 M4189444 00000298850MR9 M4198087 00000302544MR2 M41981124 00000300589MR9 M4200625 00000293042MR8 M4215566 00000306096MR9 M4484105 00000290985MR1 M4484966 00000297468MR1 M4490626 00000000UA0072 M45052106 00000297701MR5 M5480767 00001250FMM02X M5484837 00000297861MR7 M5484960 00000303323MR0 M5484987 00000000UA0105 M9481853 00000298385MR6 M9886845 00000000UA0070 N4192951 00000306296MR5 RE1046MR01 00000301236MR6 X106415405 00000303774MR4 X117934012 00000302996MR4 X148299404 00001112FMM084 X178710401 00000296814MR7 X2181501 00000303449MR3 X24481303 00000301125MR1 X4205001 00000301775MR3 X4211004 00000299633MR8 X4479201 00000000UA0016 X59007321 00000292928MR9 X59655523 00001220FMM01E X669977014 00000296499MR7 X687234009 00001250FMM02L X90281610 00000000HM0698 X1478401 00000000HM0721 E4167655 00000000HM0746 M4409435 00000000HM0812 LY1086MR02 00000303804MR9 RU1086MR03 00000000HM0555 RU1153MR01 00000307354MR1 RU1516MR01 00000000HM0827 RU1857MR05 00000000HM0716 RU2551MR01 00000000HM0747 RU8438MR02 00000000UA0229 RU8438MR03 00000000HM0824 X756087016 00000305675MR1 00001308FMM014 00001308FMM05R 00001309FMM05P 00000000HM0737 PF1000MR02 00000301873MR6 125995MR01 00000306010MR0 446281MR01 00000301543MR5 493519MR04 00000301913MR0 604529MR01 00000293440MR4 615010MR01 00000298665MR1 662455MR01 00000305980MR5 805534MR01 00000302543MR4 CC4400MR02 00000302991MR5 CC5340MR01 00000000UA0058 HC3068MR01 00000298676MR8 HC6474MR01 00000299261MR8 HWIL01MR01 00000301824MR9 PC0352MR02 00000000UA0163 PC3003MR01 00000000HM0491 PC4318MR02 00000288156MR3 PC7479MR08 00001236FMM013 PC7479MR10 00001301FMM051 PC8740MR02 00001117FMM0CP PC9595MR01 00000000UA0078 PC9953MR01 00000301850MR4 PKOB02MR06 00000000UA0015 PNUE08MR01 000001106XF039 RMUE01MR03 00000298332MR8 RMUE01MR04 00000000UA0114 UC2547MR01 00000292292MR0 HC1627MR04 00000000HM0658 PC4297MR02 00000000HM0733 418262MR01 00000000HM0790 220068MR01 00000000HM0700 PC1009MR01 00000000HM0795 387194MR01 00000000HM0810 HC2259MR02 00000000HM0813 HC3702MR01 00000000UA0246 HC0220MR03 00000308836MR6 123702MR02 00001117FMM0CU 00000293710MR0 H10645MR17 00000297155MR4 H1943MR12 00000300763MR0 828270036 00000000HM0685 828270037 00001307FMM04K 00000000UA0051 HU1098MR02 00000300561MR8 83027000042711 00000000UA0024 83027000049312 00000301544MR3 83027003811911 00000000UA0087 83027062157412 00000304074MR8 83027829851812 00000000UA0025 83027848548411 00000000UA0120 83027840038612 00000305046MR5 83027860027512 00000000UA0180 83027000013713 00000306902MR8 83027200005613 00000000HM0572 83027600046413 00000000HM0789 83027605456914 00000000UA0210 83027200034313 00001236FMM05Y 83049200034313 00001117FMM0C3 00001215FMMOMD 00000288909MR5 835270017 00001203FMM0V5 835270026 00000000HM0762 835270039 00000000UA0205 IE1010MR01 00000291778MR9 IL1020MR04 00000294771MR1 IL1028MR05 00000296834MR5 IL1041MR10 00000301585MR6 IL1059MR01 00000304405MR4 A126322010 00000291345MR7 A5108257 00000294545MR9 A51152177 00000302201MR9 A5127236 00000306070MR4 A5164526 00000303324MR8 A5274842 00000293613MR6 A5279314 00000000HM0601 A5295818 00001223FMM08V A5303339 00000304169MR6 A5360411 00000000000002 A5401395 00000296820MR4 A5624132 00000304354MR4 A5808528 00000305465MR7 A5808532 00000301191MR3 A5992703 00000299454MR9 B51142110 00000300591MR5 B5129914 00000000UA0063 B5129925 00000297807MR0 D5354206 00000295757MR9 F5119155 00000291184MR0 J5274809 00000000HM0743 A5312220 00000299418MR4 A5278404 00000000HM0823 A5196821 00000000HM0797 00000308748MR3 00001308FMM01C 00000295180MR4 EM0001 00000294943MR6 EM0002 00000296560MR6 EM0003 00000299147MR9 EM0004 00000299293MR1 EM0005 00000299330MR1 EM0006 00000298566MR1 EM0007 00000299545MR4 EM0009 00000299455MR6 EM0010 00000300791MR1 EM0011 00000301194MR7 EM0012 00000301577MR3 EM0013 00000301458MR6 EM0014 00000301925MR4 EM0015 00000299546MR2 EM0016 00000299407MR7 EM0017 00000301970MR0 EM0018 00000299853MR2 EM0019 00000302689MR5 EM0020 00000300734MR1 EM0021 00000302920MR4 EM0022 00000303054MR1 EM0023 00001106XF5134 EM0030 00000301586MR4 EM0101 00000302493MR2 EM0102 00000303852MR8 EM0103 00000305622MR3 EM0104 00001219FMM0H1 EM0105 00001221FMM06N EM0107 00000000HM0580 EM0108 00000302915MR4 EM0110 00000302516MR0 EM0111 00001203FMM0VD EM0119 00000303854MR4 EM0123 00000305174MR5 EM0125 00000304473MR2 EM0200 00000000UA0020 EM0201 00000000UA0018 EM0202 00000000UA0040 EM0203 00000000UA0036 EM0204 00000000UA0009 EM0205 00000000UA0106 EM0206 00000000UA0108 EM0207 0000000UA0107A EM0208 00000000UA0134 EM0209 00000000UA0094 EM0210 00000000UA0130 EM0211 00000000UA0126 EM0212 0000000UA0098A EM0213 00000000UA0135 EM0214 00000000UA0059 EM0215 00000000UA0145 EM0216 00000000UA0152 EM0217 00000000UA0133 EM0218 00000000UA0142 EM0219 00000000UA0113 EM0220 00000000UA0161 EM0221 00000000UA0109 EM0222 00000000UA0129 EM0223 00000000UA0123 EM0224 00001227FMM00C EM0225 00001250FMM02G EM0226 00001250FMM01W EM0227 00000000UA0182 EM0228 00000000UA0131 EM0230 00000000UA0140 EM0250 00000305684MR3 EM0240 00000305987MR0 EM0241 00000000HM0654 EM0112 00000000UA0196 EM0231 00000000UA0197 EM0229 00000000HM0738 EM0120 00000000HM0724 EM0115 00000000HM0761 EM0106 00000000UA0202 EM0233 00000000UA0204 EM0235 00000000UA0208 EM0234 00000000UA0213 EM0232 00000000UA0216 EM0272 00000000UA0223 EM0237 00001215FMM0ME EM0024 00000000HM0756 EM0109 00000000UA0125 EM0236 00000000UA0220 EM0271 00000295486MR5 EX0002 00000301726MR6 EX0001 00000000HM0778 00000000HM0794 00000000HM0796 00000000HM0799 00000000HM0803 00000000HM0805 00000000HM0816 00000000UA0154 00000000UA0241 00000000UA0247 00000000UA0250 00000000UA0254 00000000UA0255 00000000UA0257 00000000UA0259 00000000UA0266 00000000UA0267 00000000UA0271 00000301598MR9 00000303853MR6 00000304557MR2 00000307534MR8 00000307569MR4 00000308111MR4 00000308242MR7 00000308326MR8 00000308360MR7 00000308514MR9 00000308515MR6 00000308548MR7 00000308549MR5 00000308592MR5 00000308594MR1 00000308596MR6 00000308597MR4 00000308752MR5 00000308757MR4 00000308799MR6 00000309050MR3 00000309053MR7 00000944BD616D 00001011BD663B 00001011BD665C 00001026XF515D 00001044XF5031 00001106XF502E 00001140FMM0FL 00001203FMM0V2 00001235FMM05L 00001236FMM016 00001236FMM05B 00001236FMM05E 00001236FMM05T 00001236FMM05U 00001236FMM05V 00001308FMM00E 00001308FMM00N 00001308FMM00W 00001308FMM005 00001308FMM02J 00001308FMM02L 00001308FMM020 00001308FMM022 00001308FMM027 00001308FMM03L 00001308FMM05M 00001309FMM05Y 00001309FMM06A 00001309FMM08Y 00001203FMM0UM KA1044MR01 00000297007MR7 850270329 00000298272MR6 850270337 00000298331MR0 850270341 00000299419MR2 850270347 00000301050MR1 850270351 00000300733MR3 850270367 00001101XF5039 850270370 00001026XF515A 850270377 00000300931MR3 850270385 00001204FMM04V 850270386 00000000UA0137 850270409 00000000UA0119 850270411 00000000UA0112 850270414 00001018XF5029 850270423 00000000UA0165 850270426 00000000UA0170 850270427 0000000UA0081C 850270430 00000000UA0230 850270436 00001233FMM06M 0002937140 00000301844MR7 KW1002MR01 00001236FMM01Y KW1003MR01 00000298211MR4 KW1100MR01 00000299854MR0 KW1102MR01 00001236FMM00N KW1112MR01 00000000HM0768 KW1001MR04 00000307817MR7 KW1005MR04 00001301FMM04M LB1006MR02 00000000UA0164 LB1160MR02 00000000UA0043 LB1331MR01 00000302750MR5 LB1331MR02 00000301503MR9 LB1348MR01 00000000HM0730 LB1250MR01 00000299521MR5 MQ1000MR01 00000294156MR5 2806034DVR750 00000302922MR0 MR302922MR0 00000303872MR6 MR303872MR6 00000000HM0678 MR307145MR3 00000305378MR2 MRHM0503 00000301495MR8 MRHM0562 00000308183MR3 MR308183MR3 00001026XF5174 MRWB0632 00001234FMM0HT MRHM0828 00000307505MR8 00001308FMM062 00000000HM0397 MA1135MR02 00000304910MR3 AMS0424 00000292216MR9 RTD0125 00000293603MR7 RTD0127 00000303279MR4 RTD0156 00000000UA0080 RTD0191 00000301256MR4 RTD0422 00000304018MR5 TLB0229 00000304579MR6 UDN0120 00000000UA0095 UDN0121 00001106XF50E1 00001220FMM01F NC1028MR01 00000288409MR6 920279028 00001140FMM0G4 920279031 00000000HM0498 920279032 00001308FMM052 85092252519 00000297987MR0 NO1009MR02 00000295830MR4 NO1017MR03 00000304318MR9 NO1146MR02 00001106XF5121 OM1010MR01 00000296493MR0 PL1539MR01 00001106XF5132 PL1735MR02 00000306315MR3 PL1735MR03 00000296622MR4 PL1803MR01 00000303814MR8 PL2762MR01 00001105XF5047 PL2853MR01 00000305424MR4 PL2902MR01 00000000HM0613 PL1196MR01 00000000UA0190 600042MR02 00000000HM0809 PL1501MR03 00001308FMM05X PL3105MR01 00000307613MR0 PL3116MR01 00000305814MR6 00000305118MR2 MR16061YR4 00000298309MR6 QA1044MR01 00000000UA0221 QA1042MR01 00000000UA0079 RO1098MR02 00000300865MR3 600098MR01 00000304404MR7 RU1089MR05 00001233FMM06U RU1092MR02 00000301026MR1 RU1716MR01 00000301051MR9 RU1857MR03 00000305404MR6 RU2527MR01 00001101XF5070 RU2580MR02 00001251FMM032 RU3431MR01 00000296594MR5 RU3508MR01 00000300705MR1 RU3894MR01 00000301914MR8 RU3932MR01 00000303355MR2 RU6340MR01 00001105XF504C RU7762MR01 0000000UA0024A RU5599MR01 00000000HM0668 RU2526MR02 00000000HM0677 RU8282MR01 00000000HM0820 RU3637MR01 00000000HM0475 RU7620MR01 00000000UA0227 RU8438MR01 00000308901MR8 RU8541MR01 00001102XF500D 00000296613MR3 SA1011MR03 00000000HM0263 SA1011MR04 00000299965MR4 SA1012MR02 00000303776MR9 SA1031MR02 00000000UA0022 SA1033MR01 00000298266MR8 SA1052MR03 00000300882MR8 SA1058MR02 00000299951MR4 SA1114MR01 00000303644MR9 SA1175MR01 00000000HM0597 SA1255MR02 00000293984MR1 SA2180MR02 00000303666MR2 SA2281MR01 00000000HM0596 SA2315MR01 00000000HM0741 SA1014MR03 00000000HM0785 SA1037MR02 00000000HM0786 SA1004MR03 00000000HM0751 SA1026MR01 00000000HM0807 SA1188MR04 00000000HMO822 SA2143MR01 00000306645MR3 SA2304MR01 00000000HM0776 SA2308MR01 00000000HM0834 SA2385MR01 00000000HM0798 SA1253MR01 00000309114MR7 00000944BD6167 00001308FMM04K 00000000HM0615 SA1051MR02 00000000HM0723 SA1054MR03 00000000HM0732 SA1054MR04 00000000UA0127 SA1223MR01 00001251FMM00P RS4199MR01 00000306069MR6 RS4222MR01 00000000UA0023 847270026 00000301494MR1 847270027 00001301FMM04C 847270031 00000299140MR4 ZA2195MR01 00000299452MR3 CPZ43620 00000300452MR0 CPZ43623 00000301496MR6 DPN25113 00000000UA0082 DPN26332 00000302432MR0 DPN88623 00000297154MR7 MEX68909 00000000UA0045 MPX94401 00000302795MR0 NEV13613 00000301432MR1 NP739728 00000305821MR1 UPW07915 00000000HM0607 NP473629 00000293000MR6 A010MR06 00000295710MR8 A010MR07 00000000UA0039 A010MR08 00000303357MR8 A101MR01 00000304252MR0 A106MR01 00000293521MR1 AC001MR01 00000298674MR3 E001MR02 00000300298MR7 E001MR03 00000301229MR1 F009MR01 00000295538MR3 G001MR01 00000291675MR7 K002MR02 00000303993MR0 M001MR01 00000000UA0148 M001MR02 00000000UA0155 M004MR01 00000293920MR5 N002MR02 00000304828MR7 N004MR01 00000000UA0162 O009MR03 00000296547MR3 Z001MR03 00000000HM0659 A020MR04 00000308132MR0 T002MR01 00000000UA0035 120810MR02 00001251FMM00X 122002MR01 00000301293MR7 350010MR04 00000294516MR0 475290MR01 00000298944MR0 492360MR01 00000303992MR2 541010MR03 00000301971MR8 541010MR04 00000299292MR3 690120MR01 00000297386MR5 697040MR01 00000301963MR5 724010MR04 00000297175MR2 786090MR06 00000305100MR0 788000MR01 00000000UA0049 850020MR02 00000297422MR8 899010MR03 00000306909MR3 387040MR10 00000000UA0207 120810MR03 00000000HM0793 959204MR01 00000903BD55D3 853270103 00000944BD6159 853270104 00001009BD65E7 853270109 00001101XF5037 853270111 00001106XF5052 853270113 00001106XF5035 853270118 00001106XF5078 853270119 00000300907MR3 853270120 00001106XF5080 853270125 00000304853MR5 853270127 00000305636MR3 853270128 00000306097MR7 853270130 00001301FMM04J 853270135 00000000HM0766 853270137 00000000HM0825 853270140 00000000HM0680 856270062 00000000HM0621 TN1624MR01 00000000UA0110 26001MRS01 00000299646MR0 06002MRS04 00000300796MR0 06139MRS01 00000303629MR0 34006MRS04 00000000UA0102 34348MRS01 00000000HM0633 34368MRS01 00000000UA0097 AE1016MR01 00000301047MR7 AE1212MR01 00000308761MR6 00001308FMM02N 00000299340MR0 00010MRS01 00001250FMM038 00010MRS02 00000300712MR7 00040MRS01 00001233FMM070 00040MRS02 00000294967MR5 00100MRS01 00000296514MR3 00105MRS02 00000297132MR3 00109MRS01 00000298493MR8 00131MRS02 00000295709MR0 00200MRS04 00000299684MR1 00223MRS03 00000292973MR5 00242MRS02 00000298501MR8 00269MRS04 00000303638MR1 00289MRS01 00000301872MR8 00440MRS07 00000299825MR0 00487MRS03 00000296321MR3 00506MRS01 00001251FMM00V 00507MRS01 00000303822MR1 00632MRS01 00000304078MR9 00680MRS01 00000299685MR8 01305MRS01 00000000HM0660 05169MRS02 00000029804MR5 05217MRS02 00000290545MR3 10049MRS04 00000293724MR1 10050MRS03 00000303311MR5 10086MRS03 00000000HM0364 10177MRS01 00000302675MR4 10223MRS01 00000291274MR9 10307MRS03 00000301199MR6 10390MRS01 00000306126MR4 10429MRS01 00000293642MR5 10448MRS02 00000303766MR0 10580MRS01 00000000UAOO33 10639MRS01 00000303694MR4 10671MRS01 00000000UA0037 10678MRS01 00000000HM0322 10683MRS01 00000000HM0648 20483MRS01 00000293206MR9 70001MRS09 00000303309MR9 70001MRS10 00000303280MR2 70001MRS11 00000301296MR0 70043MRS05 00000298102MR5 70065MRS03 00000294332MR2 70328MRS05 00000290456MR3 70383MRS05 00000000UA0021 70431MRS04 00000000HM0567 77266MRS02 00001245FMM044 10197MRS03 00000000HM0717 77526MRS01 00000000HM0787 IE1509MR01 00000000HM0709 10462MRS02 00000000UA0265 00230MRS01 00000000HM0811 00244MRS02 00000000HMO821 10307MRS04 00000000HM0819 10537MRS01 00000308595MR8 10692MRS01 00001308FMM053 00000300689MR7 2948529MR 00000000HM0359 UZ1021MR01 00000000HM0622 UZ1010MR01 00000000HM0670 UZ1031MR01 00000304170MR4 MRHM0454 00000309113MR9 00001308FMM02X Class II GE Healthcare has recently become aware of a potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the Endbell. This overheating has occurred only while units were being serviced by GE service engineers during repeated evaluation scanning. However, the issue could also occur in Clinical mode. GE Healthcare, LLC
Food Sprouts Farmers Market Organic Whole Black Peppercorns, 2.12oz., UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Packaged in glass jars with plastic lid. Product labeling reads in part:"SPROUTS FARMERS MARKET organic Black Peppercorns ***NET WT 2.12 OZ (60g)***Manufactured Exclusively For Sprouts Farmers Market Phoenix, Arizona 85028***www.sprouts.com***SP00056***8 74875 00425 4***". UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Expiration 10/2016 (Lot 3287) and 09/2016 (Lot 3246). Class I Sprouts Farmers Market, Inc. is recalling Organic Whole Black Peppercorns, Lot 3287 after FDA test results revealed the presence of Salmonella and Lot 3246 as precaution because it has the potential to be contaminated with Salmonella. Sprout's Farmers Market
Food 1) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 11.3 Kg 25 LB. Packaged in corrugated cardboard boxes. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-82603-9.; 2) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 453 g 16 OZ. Packaged in foil pouches. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-02603-3; 3) Frontier Natural Products Co-op, Black Peppercorns Whole. Net WT. 2.12 OZ (60 g). Packaged in glass jars. Distributed by Frontier Natural Products Co-op, Norway, IA. UPC 0-89836-18435-1; 4) Simply Organic, black peppercorns. NET WT. 2.65 OZ. (75g). Packaged in glass jars. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-18524-2.; 5) Simply Organic, Adjustable Grinder Cap, daily grind. NET WT. 2.65 OZ. (75g). Packaged in glass jars with a grinder cap. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.; 6) Simply Organic, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19210-3.; 7) Simply Organic, Adjustable Grinder, Broyeur Réglable, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.; 8) 365, Black Peppercorns, NET WT 1.87 OZ (53g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44497-6; 9) 365, Black Peppercorns, NET WT 2.12 OZ (60g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44563-8.; 10) 365, Black Peppercorns, NET WT 8.08 OZ (229g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44511-9.; 11) 365, Organic Black Peppercorns Grains de Poivre noir biologique, 60g (2.12 OZ). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-73914-0; 12) Nature's Place Organic, Black Peppercorns, NET WT. 2.26 OZ (64g). Packaged in glass jars. Distributed by DZA Brands, LLC in Salisbury, NC. UPC 7-25439-95273-6; 13) Meijer Organics, Black Peppercorns, NET WT. 2.26 OZ (64g). Packaged in plastic jars. Item number ME81732. UPC 7-13733-78173-2; Lot numbers: 3246, 3226, 3256, 3288, 3232, 3233, 3280, 3246, 3287, 3260, 3267, 3247, 3221, 3262, 3294, and 3261; Class I Testing of organic whole black peppercorns revealed the presence of Salmonella Frontier Natural Products Co-op
Devices iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software. Class II Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance. Boston Scientific Corporation
Food Lisy Sweet Basil Albahaca Net WT/Cont. Neto 6oz. (171g) Item 1132 www.lisycorp.com Packed on a clear plastic container with a UPC # 0 96786 30032 8 Item 1132 Lot #'s A013 0518 and A014 0518 Class I FDA sample collected was found to be positive for salmonella spp. Lisy Corp.
Food Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags. Pack on dates: 28-14, 13-14, 351-13, 336-13, 322-13, 305-13, 290-13, 281-13, 266-13, 252-13, 245-13 Class I Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado based natural grocery chain, is recalling multiple lots of Natural Grocers brand Organic Black Peppercorns as the product has the potential to be contaminated with Salmonella. Natural Grocers by Vitamin Cottage
Devices Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Devices Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Devices Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Devices Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens sexual excitement and pleasure. Lot 8-94034 Class II Firm is not registered as a drug manufacturer. Altasource LLC dba Meta Labs LLC
Food Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873 American Pop Corn Company, Sioux City, IA. Best By 03/27/15 (Julian date) 4086 Class II The product has the potential to be contaminated with stainless steel metal fragments. American Pop Corn Co
Food Jolly Time Microwave popcorn, Extra Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190008477, on the 12 count case - UPC 10028190008474 and 48 ct shipper with UPC 128190488474 American Pop Corn Company, Sioux City, IA. Best By 03/31/15 (Julian date) 4090 Class II The product has the potential to be contaminated with stainless steel metal fragments. American Pop Corn Co
Food Jolly Time Microwave popcorn, Homemade Classic Stovetop Flavor, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190007807, on the 12-ct case - UPC 10028190007804, 48-ct shipper UPC 128190487804 American Pop Corn Company, Sioux City, IA Best By code of 04/01/15 (Julian date) 4091 Class II The product has the potential to be contaminated with stainless steel metal fragments. American Pop Corn Co
Food Cinnamon Cookie Manjoo, 200g Net Weight. Packaged in clear plastic bag, 10 per bag. Product package labeled in part:"***Cinnamon Cookie (Manjoo)*** Net Wt. 200g, 7.1oz***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039219***. Production batch: 1/1/2013-03/13/2014. No codes on finished packaging. Class II CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat. CJ Bakery, INC
Food Madeline, 80g Net Weight. Packaged in clear plastic bag, 4 per bag. Product package labeled in part:"AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***. Production batch: 1/1/2013-03/13/2014 No codes on finished package. Class II CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat. CJ Bakery, INC
Food Chocolate Madeline, 80g Net Weight. Packaged in clear plastic bag, 4 per bag. Product package labeled in part:"AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***. Production batch: 1/1/2013-03/13/2014 No codes on finished package. Class II CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat. CJ Bakery, INC
Drugs Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170 Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16). Class III Subpotent Drug: Phenylephrine component is subpotent. P&L Developments, LLC
Devices Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system. Model numbers: 1065844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Class II When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report. Siemens Medical Solutions USA, Inc.
Devices ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16 Class II Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. Ev3, Inc.
Devices Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102"). Lot No. K556399, Expires 2016-10 Class II Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling. Merit Medical Systems, Inc.
Devices Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102"). Lot No. K556402, Expires 2016-10 Class II Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, lot number K556402 (186 units), which has an angled tip, standard shaft and Chinese unit labeling. Merit Medical Systems, Inc.
Drugs Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06 Lot #2802.042A, Exp. 10/2015 Class III Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith. Upsher Smith Laboratories, Inc.
-
-