Events

Recall of GE sterile drape

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

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
    52561
  • Event Risk Class
    Class 2
  • Event Number
    Z-1708-2009
  • Event Initiated Date
    2008-08-15
  • Event Date Posted
    2009-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84753
  • 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
    Cover, barrier, protective - Product Code MMP
  • Reason
    Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state. eleven complaints and 3 mdr's have been filed. no illness or injuries reported.
  • Action
    GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.

Device

GE sterile drape
  • Model / Serial
    all lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.
  • Product Description
    Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA