Events

Recall of MICROTOUCH(R), NITRILE, Powder Free, Medical Examination Gloves

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
    59777
  • Event Risk Class
    Class 2
  • Event Number
    Z-3115-2011
  • Event Initiated Date
    2011-08-04
  • Event Date Posted
    2011-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103718
  • 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
    examination gloves - Product Code LZC
  • Reason
    Gloves were inadvertently released for distribution prior to completion of testing required by the u.S. food and drug administration.
  • Action
    Ansell account managers were notified on August 4, 2011 to contact (by phone, fax, e-mail) their respective accounts and notify them of the recall situation. The Ansell account managers were provided with a copy of the recall notification to provide to their accounts. The recall notification includes a request that if these gloves have been further distributed to other customers, please advise them of the recall situation and have them return any outstanding stocks.

Device

MICROTOUCH(R), NITRILE, Powder Free, Medical Examination Gloves
  • Model / Serial
    11040193EP
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: NC, GA, IL, MO, LA, and PA
  • Product Description
    MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
  • 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