Events

Recall of Device Recall Genzyme

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genzyme Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62127
  • Event Risk Class
    Class 2
  • Event Number
    Z-1855-2012
  • Event Initiated Date
    2012-06-13
  • Event Date Posted
    2012-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109887
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Barrier, absorable, adhesion - Product Code MCN
  • 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.

Device

Device Recall Genzyme
  • Model / Serial
    Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • Product 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.
  • Manufacturer
    Genzyme Corporation

Manufacturer

Genzyme Corporation
  • Manufacturer Address
    Genzyme Corporation, 31,45,49,51,55,74,76, & 80 New York Ave., Framingham MA 01702-5733
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA