Events

Recall of Latex gloves

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gulf South Medical Supply 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
    35247
  • Event Risk Class
    Class 2
  • Event Number
    Z-0909-06
  • Event Initiated Date
    2006-04-10
  • Event Date Posted
    2006-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45605
  • 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
    Fda's laboratory analysis found holes in the gloves that exceeded the allowable limit. gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.
  • Action
    The recall is being conducted to the user level. All consignees will be notified by US postal Service letter dated April 10, 2006, first class mail, followed by a phone call. They will be instructed to check their inventory for the lot number of the recalled gloves. Customers who have the product on hand should call the firm at 904-332-4141 to make arrangement for pick up and replacement of the product.

Device

Latex gloves
  • Model / Serial
    lot/unit numbers: 04000130161, 04000130162, 04000160163, 04000130164
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed throughout the following states: PA, VA, MD, NJ, DE, NY, NH, WV, AZ and FL.
  • Product Description
    Powder Free Latex , Non-sterile Medical Exam Gloves || Cat #s: 22401 22402 22403 and 22404
  • Manufacturer
    Gulf South Medical Supply Inc

Manufacturer

Gulf South Medical Supply Inc
  • Manufacturer Address
    Gulf South Medical Supply Inc, 4345 Southpoint Blvd, Jacksonville FL 32216-8013
  • Source
    USFDA