BEUDAMED
    FDA Recall Terminated

    Cruciform Slit Valve

    Recall: Z-0585-04 · Initiated January 6, 2004

    Recall

    Recall Number
    Z-0585-04
    Event Number
    28392
    Firm
    Phoenix Biomedical
    FEI Number
    2518608
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 6, 2004
    Posted
    July 20, 2004
    Terminated
    March 3, 2004
    Address
    2495 General Armistead Ave, Norristown, PA, 19403

    Description

    Cruciform Slit Valve

    Reason

    mislabeled - product actually Single Valve

    Action

    The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.

    Distribution

    The product was shipped to two hospitals - one in CA and one in AZ.

    Quantity

    5 units