BEUDAMED
    FDA Recall Terminated

    Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. The catheter is designed for external and internal percutaneous drainage of the biliary system.

    Recall: Z-1901-2009 · Initiated July 1, 2009

    Recall

    Recall Number
    Z-1901-2009
    Event Number
    52717
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 1, 2009
    Posted
    August 27, 2009
    Terminated
    December 2, 2011
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. The catheter is designed for external and internal percutaneous drainage of the biliary system.

    Reason

    Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the

    Action

    Boston Scientific issued an "Urgent Medical Device Recall -Immediate Action Required" letter dated July 1, 2009. The letter was addressed to Risk Manger / Field Action Contact describing the problem and units affected and that further distribution or use of affected product should cease immediately. The Reply Verification Tracking Form enclosed with the letter was requested to be completed and returned. For further information, contact Boston Scientific at 1-508-683-6036.

    Distribution

    Worldwide Distribution -- United States (AZ, AR, CO, DE, FL, GA, MI, MT, NE, NC, OH and WI), Spain, Finland and Netherlands.

    Quantity

    79 units (1 box = 1 unit)