Events

Recall of Latex examination gloves, Uniseal brand.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Healthcare Products Inc.

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
    25611
  • Event Risk Class
    Class 2
  • Event Number
    Z-0635-03
  • Event Initiated Date
    2002-07-23
  • Event Date Posted
    2003-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26151
  • 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
    Latex Patient Examination Glove - Product Code LYY
  • Reason
    Unfit for intended use due to stickiness.
  • Action
    Firm sent recall letter 7/23/2002.

Device

Latex examination gloves, Uniseal brand.

Manufacturer

American Healthcare Products Inc
  • Manufacturer Address
    American Healthcare Products Inc, 3260 Industry Drive, Signal Hill CA 90806-4014
  • Source
    USFDA