Events

Recall of Seprafilm

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
    47758
  • Event Risk Class
    Class 2
  • Event Number
    Z-1648-2008
  • Event Initiated Date
    2008-04-10
  • Event Date Posted
    2008-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70077
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Sterility may be compromised.
  • Action
    Genzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.

Device

Seprafilm
  • Model / Serial
    Lot number: 07NP181 Exp June 2010
  • Product Classification
    General and Plastic Surgery Devices
  • Distribution
    Nationwide Korea, Taiwan, Japan
  • Product Description
    Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only || Product Number: 4301-05
  • Manufacturer
    Genzyme Corporation

Manufacturer

Genzyme Corporation
  • Manufacturer Address
    Genzyme Corporation, 45, 51-80 New York Ave and, One Mountain Rd., Framingham MA 01701
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA