BEUDAMED
    FDA Recall Terminated

    V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.

    Recall: Z-0982-03 · Initiated April 15, 2003

    Recall

    Recall Number
    Z-0982-03
    Event Number
    26369
    Firm
    Ventlab Corporation
    FEI Number
    1314417
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 15, 2003
    Posted
    July 8, 2003
    Terminated
    August 7, 2003
    Address
    2934 Hwy 601, North Mocksville, NC, 27028

    Description

    V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.

    Reason

    Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.

    Action

    Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.

    Distribution

    The product was distributed to one consignee in CA. The cases were returned to the recalling firm.

    Quantity

    9 cases (10 units per case)