Events

Recall of 8" x 4" 16ply Dual XRay Gauze

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Medsurg Connection, 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
    61681
  • Event Risk Class
    Class 2
  • Event Number
    Z-1518-2012
  • Event Initiated Date
    2012-04-09
  • Event Date Posted
    2012-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108705
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Reason
    The lots of x-ray gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
  • Action
    International Medsurg Connection notified their direct accounts via telephone, e-mail and/or fax on April 9, 2012, informing them of the foreign material contamination of the gauze, and requesting them to quarantine all affected lots in inventory, cease distribution of the affected product, and notify any customers at the retail level to remove and discard these products. Any questions were directed to (847) 619-9926.

Device

8" x 4" 16ply Dual XRay Gauze
  • Model / Serial
    item IMSGZXX8416-10, lot number 11-6559-1
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Illinois, South Carolina, Texas and Virginia
  • Product Description
    8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZXX8416-10 || For use to control bleeding and absorb fluid.
  • Manufacturer
    International Medsurg Connection, Inc.

Manufacturer

International Medsurg Connection, Inc.
  • Manufacturer Address
    International Medsurg Connection, Inc., 935 N Plum Grove Rd Ste F, Schaumburg IL 60173
  • Manufacturer Parent Company (2017)
    International Medsurg Connection Inc.
  • Source
    USFDA