BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

    Recall: Z-1025-2010 · Initiated October 12, 2009

    Recall

    Recall Number
    Z-1025-2010
    Event Number
    53650
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JSM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2009
    Posted
    March 8, 2010
    Terminated
    March 10, 2010
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

    Reason

    A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.

    Action

    Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at [email protected] or via telephone at 1-800-6310174.

    Distribution

    Nationwide distribution to hospitals and medical device distributors.

    Quantity

    226900