Events

Recall of Dow Corning Silastic brand Medical Adhesive Silicone

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

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
    27225
  • Event Risk Class
    Class 3
  • Event Number
    Z-0029-04
  • Event Initiated Date
    2003-09-05
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29459
  • 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
  • Reason
    May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
  • Action
    Customers were notified via phone call and by letter dated September 5, 2003. Customer were asked to return unused materials.

Device

Dow Corning Silastic brand Medical Adhesive Silicone
  • Model / Serial
    material number 3242901; lots 0001531727, 001583486 and 0001671243. material number 3242897; lot 0001604743.
  • Distribution
    United States.
  • Product Description
    Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
  • Manufacturer
    Dow Corning Corp.

Manufacturer

Dow Corning Corp.
  • Manufacturer Address
    Dow Corning Corp., 12334 Geddes Rd., Hemlock MI 48626
  • Source
    USFDA