BEUDAMED
    FDA Recall Terminated

    The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.

    Recall: Z-0519-06 · Initiated November 28, 2005

    Recall

    Recall Number
    Z-0519-06
    Event Number
    34215
    Firm
    Gish Biomedical Inc
    FEI Number
    2021836
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 28, 2005
    Posted
    February 14, 2006
    Terminated
    June 21, 2007
    Address
    22942 Arroyo Vis, Rancho Santa Margarita, CA, 92688-2600

    Description

    The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.

    Reason

    Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.

    Action

    The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. 11/14/2005 The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Customer Service will, at the same time, issue a SORMA for the return of coated oxygenators from the consignee. Sequester the coated oxygenator for return to Gish Biomedical. If the consignees prefer, they can provide a contact name and the number of packages to be picked up and the firm will issue a Federal Express call tag for pick-up at the earliest scheduled time.

    Distribution

    Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico.

    Quantity

    2,306