BEUDAMED
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    PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·April 23, 2007

    Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·August 17, 2007

    Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M001761101 Contour SE/100-300/1mL/2vials M001761122 Contour SE/100-300/1mL/5vials M001761141 Contour SE/100-300/2mL/2vials M001761162 Contour SE/100-300/2mL/5vials M001761201 Contour SE/300-500/1mL/2vials M001761222 Contour SE/300-500/1mL/5vials M001761241 Contour SE/300-500/2mL/2vials M001761262 Contour SE/300-500/2mL/5vials M001761301 Contour SE/500-700/1mL/2vials M001761322 Contour SE/500-700/1mL/5vials M001761341 Contour SE/500-700/2mL/2vials M001761362 Contour SE/500-700/2mL/5vials M001761401 Contour SE/700-900/1mL/2vials M001761422 Contour SE/700-900/1mL/5vials M001761441 Contour SE/700-900/2mL/2vials M001761462 Contour SE/700-900/2mL/5vials M001761501 Contour SE/900-1200/1mL/2vials M001761522 Contour SE/900-1200/1mL/5vials M001761541 Contour SE/900-1200/2mL/2vials M001761562 Contour SE/900-1200/2mL/5vials

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NAJ·August 17, 2009

    The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com*** Product Recall: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm, 50mm, and 55mm, designated left and right. The mandibular prosthesis is offered in 3 styles:Standard, Offset, and Narrow, to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code MPL·April 7, 2010

    The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. The component is labeled in part: "REF: 24-6546***TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com*** Product Usage: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm, 50mm, and 55mm, designated left and right. The mandibular prosthesis is offered in 3 styles:Standard, Offset, and Narrow, to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code MPL·April 7, 2010

    On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label

    FDA Recall
    Terminated ·Varian, Inc.·Product code DML·July 18, 2003

    GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)

    FDA Recall
    Terminated ·Gentian AS Bjornasveien·Product code NDY·September 2, 2020

    BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin Lot 6073436

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·January 27, 2007

    Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code LCH·December 13, 2002

    Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code LCH·December 13, 2002

    1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMF·March 23, 2017

    BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·November 24, 2008

    STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JOX·December 20, 2002

    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KYZ·February 6, 2018

    BD 1mL SafetyGlide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·July 24, 2006

    Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NEP--·April 26, 2004

    Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMI·June 29, 2004