BEUDAMED
    FDA Recall Terminated

    AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00

    Recall: Z-0503-06 · Initiated December 1, 2005

    Recall

    Recall Number
    Z-0503-06
    Event Number
    34120
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 1, 2005
    Posted
    February 8, 2006
    Terminated
    May 11, 2006
    Address
    2345 Waukegan Rd, Ste 120, Bannockburn, IL, 60015-1580

    Description

    AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00

    Reason

    Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.

    Action

    Teleflex Medical sent recall letters dated 12/1/05 to their direct accounts on the same date via UPS overnight. The accounts were informed that the lot did not pass validated sterility test requirements, and were instructed to cease distribution and use of the lot and quarantine it for return to Teleflex Medical, Durham, NC. The wholesalers were requested to notify their customers of the recall and have them return their inventory of the lot to the direct account for consolidation and return to Teleflex. Questions were directed to Dan Daily at 1-800-334-9751, ext. 4948.

    Distribution

    Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.

    Quantity

    1050 units