BEUDAMED
    FDA Recall Terminated

    Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

    Recall: Z-2894-2011 · Initiated June 17, 2011

    Recall

    Recall Number
    Z-2894-2011
    Event Number
    59113
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 17, 2011
    Posted
    July 29, 2011
    Terminated
    October 1, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

    Reason

    Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.

    Action

    Arrow International, Inc. sent an "Urgent Medical Device Recall" letter dated June 17, 2011 to all affected customers. The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer. For additional information call 800 233-3187.

    Distribution

    Nationwide Distribution including the state of North Carolina.

    Quantity

    95 kits