BEUDAMED
    FDA Recall Terminated

    Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).

    Recall: Z-1061-05 · Initiated May 20, 2005

    Recall

    Recall Number
    Z-1061-05
    Event Number
    32267
    Firm
    Maquet Inc
    FEI Number
    3008355164
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 20, 2005
    Posted
    August 3, 2005
    Terminated
    October 3, 2006
    Address
    1140 Route 22 East, Bridgewater, NJ, 08807-2912

    Description

    Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).

    Reason

    Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.

    Action

    Maquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary.

    Distribution

    Nationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet.

    Quantity

    890 units