BEUDAMED
    FDA Recall Terminated

    Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000

    Recall: Z-0141-2010 · Initiated August 28, 2009

    Recall

    Recall Number
    Z-0141-2010
    Event Number
    53137
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    FCG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 28, 2009
    Posted
    November 9, 2009
    Terminated
    May 12, 2010
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000

    Reason

    The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.

    Action

    Cardinal Health sent Urgent Product Recall letters dated 8/28/09 to all customers who received the product during the recalled period on the same day via UPS Next Day Air. The accounts were informed of the problem with the cannula, and were instructed to functionally test the cannula by passing the toothed cutter within it to ensure the cutter advances freely into the cannula. If any restriction is noticed, the product should be segregated and returned to Cardinal Health. The accounts were requested to complete and return by fax the enclosed acknowledgement form, indicating the number of affected cannulas being returned. Any questions were directed to V. Mueller Customer Service at 800-323-9088.

    Distribution

    Nationwide distribution.

    Quantity

    19 units