BEUDAMED
    FDA Recall Terminated

    Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220

    Recall: Z-0384-05 · Initiated September 28, 2000

    Recall

    Recall Number
    Z-0384-05
    Event Number
    30656
    Firm
    Hydro Med Products, Inc
    FEI Number
    1625657
    Product Code
    MMP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 28, 2000
    Posted
    January 6, 2005
    Terminated
    April 1, 2008
    Address
    2930 Ladybird Ln, Dallas, TX, 75220-1417

    Description

    Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220

    Reason

    Defective packaging, potential for breech in sterility.

    Action

    The firm initiated the recall on 09/28/00 via letter. The firm followed up with phone call contact to 100% of customers.

    Distribution

    The product was distributed nationwide to distributors and hospitals in the following states IA, WV, OR, PA, CA, and TN

    Quantity

    35 cases, 10 units per case