Events

Recall of Device Recall Radiation Reduction Gloves

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

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
    48971
  • Event Risk Class
    Class 2
  • Event Number
    Z-2335-2008
  • Event Initiated Date
    2008-07-07
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72433
  • 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
    Glove, patient examination, specialty - Product Code LZC
  • Reason
    Radiation reduction gloves were labeled as "latex-free", but contain natural rubber latex.
  • Action
    On 07/03/2008, all consignees were notified by telephone and letter titled URGENT MEDICAL DEVICE RECALL. They were instructed to immediately cease distribution/use of any affected product and arrange for its return. Contact number for Integra is 800-241-2210.

Device

Device Recall Radiation Reduction Gloves
  • Model / Serial
    Lot No: W0806178, W0806179, and W0806177
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.
  • Product Description
    Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.
  • Manufacturer
    Integra Pain Management

Manufacturer

Integra Pain Management
  • Manufacturer Address
    Integra Pain Management, 3395 W 1820 S, Salt Lake City UT 84104-4921
  • Manufacturer Parent Company (2017)
    Integra Pain Management
  • Source
    USFDA