BEUDAMED
    FDA Recall Terminated

    ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridges are packaged per box.

    Recall: Z-0656-05 · Initiated February 28, 2005

    Recall

    Recall Number
    Z-0656-05
    Event Number
    31351
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2005
    Posted
    March 25, 2005
    Terminated
    February 21, 2007
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridges are packaged per box.

    Reason

    The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

    Action

    The recalling firm sent a letter, dated 2/28/05 to consignees.

    Distribution

    The product was distributed throughout the United States and to foreign customers located in Saudi Arabia, Egypt, United Kingdom, Germany, France, Republic of Panama, Turkey, Hong Kong, Taiwan, Puerto Rico, Spain, Japan, China, Republic of Singapore, Argentina, Italy, New Zealand, Australia, Canada, Czech Republic, Sweden, Portugal, Slovenia, Poland, Hungary, and the United Arab Emirate.

    Quantity

    15,462 boxes.