BEUDAMED
    FDA Recall Terminated

    Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.

    Recall: Z-0025-05 · Initiated September 29, 2004

    Recall

    Recall Number
    Z-0025-05
    Event Number
    30184
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JTS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2004
    Posted
    October 20, 2004
    Terminated
    February 8, 2005
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.

    Reason

    Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.

    Action

    The recalling firm notified distributors and direct accounts by fax, certified letter, and e-mail on 9/29/04. The notifications advised that staining characteristics may not be appropriate, and that product should be discarded for replacement. Distributors were additionally requested to provide a consignee list for direct notification by BD. Consignees were requested to return response form.

    Distribution

    Product was sold to distributors and end-users nationwide and to the firm''s international affiliates.