BEUDAMED
    FDA Recall Terminated

    BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25

    Recall: Z-0406-06 · Initiated November 23, 2005

    Recall

    Recall Number
    Z-0406-06
    Event Number
    34145
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    KZJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 23, 2005
    Posted
    January 18, 2006
    Terminated
    February 1, 2006
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25

    Reason

    Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.

    Action

    The recalling firm notified distributors by letter on 11/23/05 and advised that identified lots of the devices contain a component contaminated with the bacteria Ralstonia picketti. Distributors were instructed to discontinue distribution and discard. Distributors were requested to provide consignee lists to the recalling firm for direct notification to consignees. Distributors were notified that the recalled products have been discontinued. Customers are asked to discard Liquid Activating Reagent Packets and return the response form enclosed for replacement of the packets or alternatively use existing packets by adding user supplied de-ionized or sterile water into the reagent channel of the pouch.

    Distribution

    Product was distributed to direct accounts and distributors nationwide and to international affiliated distributors.

    Quantity

    61647 boxes of 25/box