BEUDAMED
    FDA Recall Terminated

    Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central. Manufactured in the USA for: CRS Medical Diagnostics, Inc., Pewaukee, WI.

    Recall: Z-0357-2007 · Initiated October 18, 2006

    Recall

    Recall Number
    Z-0357-2007
    Event Number
    36655
    Firm
    Continental Medical Labs, Inc
    FEI Number
    2128604
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 18, 2006
    Posted
    January 18, 2007
    Terminated
    January 18, 2007
    Address
    813 Ela Ave PO Box 306, Waterford, WI, 53185-0306

    Description

    Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central. Manufactured in the USA for: CRS Medical Diagnostics, Inc., Pewaukee, WI.

    Reason

    Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.

    Action

    Consignee was notified by certified mail on 10/19/06.

    Distribution

    Product was distributed to one consignee located in Wisconsin

    Quantity

    840 kits