Events

Recall of Device Recall Ambitex NMD400 Nitrile Exam Gloves

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

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
    72078
  • Event Risk Class
    Class 2
  • Event Number
    Z-0133-2016
  • Event Initiated Date
    2015-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140214
  • 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
    Polymer patient examination glove - Product Code LZA
  • Reason
    Ambitex nitrile nmd400 exam gloves size medium on exam hold were inadvertently placed into commerce. the product was under exam hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by fda as described at 21 cfr 800.20.
  • Action
    The firm sent an Urgent: Product Recall letter dated 8/25/2015. The firm is requesting the user discontinue using and return any remaining stock of the AMBITEX Nitrile Exam Gloves because the gloves were inadvertently shipped prior to U.S. FDA releasing them for sale. Additionally, the firm requests that the customer quarantine the affected examination gloves; and return a copy of the enclosed Acknowledgment Form confirming their receipt of the Urgent recall via fax to 216-651-9760. Customer Service should be contacted at 800-GLOVES-0 to arrange for the return and credit of any on hand product that customer may have. If the customer has further distributed the affected gloves they are advised to notify their customers of the recall.

Device

Device Recall Ambitex NMD400 Nitrile Exam Gloves
  • Model / Serial
    Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. || Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1300 Waukegan Rd, Waukegan IL 60085-6724
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA