BEUDAMED
    FDA Recall Terminated

    seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

    Recall: Z-1856-2012 · Initiated June 13, 2012

    Recall

    Recall Number
    Z-1856-2012
    Event Number
    62127
    Firm
    Genzyme Corporation
    FEI Number
    1220423
    Product Code
    MCN
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 13, 2012
    Posted
    June 21, 2012
    Terminated
    July 24, 2013
    Address
    31 45, 49, 51, 55, 74, 76, &, Framingham, MA, 01702-5733

    Description

    seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

    Reason

    Sterility of product may be compromised due to packaging defect

    Action

    Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.

    Distribution

    Worldwide Distribution - US (nationwide) and the country of S. Korea

    Quantity

    1285 units