BEUDAMED
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    VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.

    FDA Recall
    Terminated ·Biomerieux, Inc.·Product code LSR·October 28, 2003

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013

    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.

    FDA Recall
    Terminated ·Naviscan PET Systems·Product code KPS·June 19, 2008

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.

    FDA Recall
    Terminated ·Naviscan PET Systems·Product code KPS·August 1, 2007

    B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-06, NDC #64054-3005-06, 5mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    B. Braun, Heparin Lock Flush Solution USP, 10 units/ml, Ref #513610, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    B. Braun, Normal Saline IV Flush, REF #513586, NDC 64054-0905-02, 5 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501.

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-02, NDC #64054-3003-02, 3mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007