BEUDAMED
    FDA Recall Terminated

    BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.

    Recall: Z-1075-05 · Initiated April 19, 2005

    Recall

    Recall Number
    Z-1075-05
    Event Number
    32005
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    GES
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2005
    Posted
    August 3, 2005
    Terminated
    October 3, 2006
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.

    Reason

    A small percentage of scalpels exhibited a 'double blade' condition.

    Action

    Letters were sent to all customers and all customers have also been contacted by phone. Letters were sent on 4/49/2005.

    Distribution

    The scalpels were distributed to kit manufacturers. These include: Cardinal Health, 1300 Waukegan Road, McGaw Park, Il 60085; Bard Health Care, 201 West Anaya Road, Hidalgo, TX 78577; Edwards Lifesciences, 6864 South 300 West, Salt Lake City, UT 84047; Avid Medical, 900 Westmount Dr., James City, VA 23168; DeRoyal Industries, PO Box 1667, Knoxville, TN 37849; Boston Scientific, 780 Brookside Dr., Owen, IN 47460; Medikmark, 3600 Burwood Dr., Waukegan Lake, IL 60085; CustoMed/Puerto Rico Hospital Supply, Carolina, PR 00987.

    Quantity

    48000 units