BEUDAMED
    FDA Enforcement Class II Terminated

    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 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-1855-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1855-2012
    Event ID
    62127
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genzyme Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    June 13, 2012
    Classification Date
    June 21, 2012
    Termination Date
    July 24, 2013
    Address
    31,45,49,51,55,74,76, & 80 New York Ave., N/A, Framingham, MA, 01702-5733, United States

    Description

    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 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

    Code Info

    Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11

    Distribution

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

    Quantity

    3880units