BEUDAMED
    FDA Recall Terminated

    Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.

    Recall: Z-0081-2007 · Initiated September 21, 2006

    Recall

    Recall Number
    Z-0081-2007
    Event Number
    36439
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    FFA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 21, 2006
    Posted
    October 28, 2006
    Terminated
    May 3, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.

    Reason

    Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.

    Action

    Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.

    Distribution

    Nationwide.

    Quantity

    80