BEUDAMED
    FDA Recall Terminated

    Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.

    Recall: Z-1499-06 · Initiated August 10, 2006

    Recall

    Recall Number
    Z-1499-06
    Event Number
    36136
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    GBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2006
    Posted
    September 13, 2006
    Terminated
    February 7, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.

    Reason

    Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.

    Action

    Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.

    Distribution

    Texas.

    Quantity

    4 units