BEUDAMED
    FDA Recall Terminated

    Vision Hollow Fiber Oxygenator with GBS Coating

    Recall: Z-0730-04 · Initiated March 4, 2004

    Recall

    Recall Number
    Z-0730-04
    Event Number
    28525
    Firm
    Gish Biomedical Inc
    FEI Number
    2021836
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2004
    Posted
    July 20, 2004
    Terminated
    January 4, 2005
    Address
    22942 Arroyo Vis, Rancho Santa Margarita, CA, 92688-2600

    Description

    Vision Hollow Fiber Oxygenator with GBS Coating

    Reason

    Customers reported leakage.

    Action

    Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.

    Distribution

    NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA

    Quantity

    950