BEUDAMED
    FDA Recall Terminated

    Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) Catalog #9158 - 1 CV split drape b) Catalog #9158CE - 8 x 1 CV split drape

    Recall: Z-0058-2007 · Initiated September 27, 2006

    Recall

    Recall Number
    Z-0058-2007
    Event Number
    36421
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2006
    Posted
    October 21, 2006
    Terminated
    May 9, 2008
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) Catalog #9158 - 1 CV split drape b) Catalog #9158CE - 8 x 1 CV split drape

    Reason

    The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

    Action

    Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.

    Distribution

    Worldwide Distribution- USA and countries of Kuwait and Australia

    Quantity

    1086 units