Events

Recall of Gammex

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
    75737
  • Event Risk Class
    Class 2
  • Event Number
    Z-0893-2017
  • Event Initiated Date
    2016-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151121
  • 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
    Surgeon's gloves - Product Code KGO
  • Reason
    Ansell healthcare products is initiating a voluntary recall involving 15 cases of gammex non latex sensitive surgical gloves because the packaged contents incorrectly included a natural rubber latex surgical glove.
  • Action
    Ansell Healthcare Products, LLC. sent an Urgent: Voluntary Surgical Glove Recall letter dated October 28, 2016, to all affected customers. The letter identified the problem the product and the action the customer needs to take. Please check your product stock at the warehouse and shelf level in order to advise us directly if any gloves having the recalled lot numbers are found. This information, along with your tracking number, must be communicated to our Customer Service Department by calling 1-800-952-9916, or by returning the attached Response Form to Ansell by fax at 1-800-722-8155, or via email customerserviceus@ansell.com . Returned product will either be replaced or credited without delay. Your Ansell representative will be available to follow up with you regarding any concerns you may have.

Device

Gammex
  • Model / Serial
    Lot 1607018105
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : PA, FL, NJ, IL and MA.
  • Product Description
    Gammex Non-Latex Sensitive Neoprene Surgical Gloves || Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka || Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium || Manufactured for/ Fabrique' pour: || Ansell Healthcare products LLC. || 1635 Industrial Road Dothan, AL 36303, USA || TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 || catalog #20277285
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • Manufacturer Address
    Ansell Healthcare Products LLC, 111 Wood Ave S Ste 210, Iselin NJ 08830-2700
  • Manufacturer Parent Company (2017)
    Ansell Ltd.
  • Source
    USFDA