BEUDAMED
    FDA Recall Terminated

    Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W. Designed to close incisions during a surgical procedure.

    Recall: Z-1610-2010 · Initiated April 1, 2010

    Recall

    Recall Number
    Z-1610-2010
    Event Number
    55215
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    GAG
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 1, 2010
    Posted
    May 19, 2010
    Terminated
    August 17, 2011
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W. Designed to close incisions during a surgical procedure.

    Reason

    The sterility of the staplers is questionable.

    Action

    Cardinal Health issued an "Urgent: Product Recall" letter dated April 1, 2010 to all customers who may have received affected product. Customers were instructed to immediately quarantine any affected inventory, return the notification acknowledgement form and return the product to the firm. For further information, contact Cardinal Health Customer Service at 1-888-444-5440.

    Distribution

    Nationwide Distribution

    Quantity

    1,638 units