Events

Recall of Device Recall ENCORE(R) UNDERGLOVE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ansell Healthcare Products 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
    59155
  • Event Risk Class
    Class 2
  • Event Number
    Z-2842-2011
  • Event Initiated Date
    2011-06-10
  • Event Date Posted
    2011-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101415
  • 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
    Powder free latex surgeons gloves - Product Code NPD
  • Reason
    Gloves do not meet the tensile requirements of astm d 3577 reducing the shelf life of the product from 5 years to 2 years.
  • Action
    Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.

Device

Device Recall ENCORE(R) UNDERGLOVE
  • Model / Serial
    All codes distributed from February 2008 through May 2011
  • Distribution
    Nationwide Distribution
  • Product Description
    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka || Surgical gloves
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • Manufacturer Address
    Ansell Healthcare Products LLC, 1635 Industrial Rd, Dothan AL 36303-5750
  • Manufacturer Parent Company (2017)
    Ansell Ltd.
  • Source
    USFDA