Events

Recall of Device Recall Vinyl PowderFree Exam 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
    63603
  • Event Risk Class
    Class 2
  • Event Number
    Z-0295-2013
  • Event Initiated Date
    2012-06-20
  • Event Date Posted
    2012-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114353
  • 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 Vinyl - Product Code LYZ
  • Reason
    Gulf south medical supply recalled their select medium and large size vinyl exam gloves because they were inadvertently shipped prior to u.S. customs clearing them for sale.
  • Action
    The firm, PSS World Medical, sent an "URGENT RECALL NOTICE" dated June 20, 2012 via USPS to all customers that received the product. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, quarantine the affected lot numbers listed in this recall and return the product; If the product was further distributed, to inform their customers of the recall and request they return the affected product directly to them; and contact their Gulf South Customer Care team via telephone at 1-800-347-2456 or email to customercare@gsms.com to request a return goods authorization. If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.

Device

Device Recall Vinyl PowderFree Exam Gloves
  • Model / Serial
    Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
  • Product Description
    Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. || Usage: Patient Examination.
  • 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