Events

Recall of Device Recall STERLING NITRILE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Halyard 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
    75663
  • Event Risk Class
    Class 2
  • Event Number
    Z-0758-2017
  • Event Initiated Date
    2016-11-10
  • Event Date Posted
    2016-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151014
  • 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
    Defects: product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
  • Action
    Consignees were notified by letter via Fed Ex on/about 11/10/2016.

Device

Device Recall STERLING NITRILE
  • Model / Serial
    Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
  • Product Description
    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
  • Manufacturer
    Halyard Health

Manufacturer

Halyard Health
  • Manufacturer Address
    Halyard Health, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • Manufacturer Parent Company (2017)
    Halyard Health Inc
  • Source
    USFDA