Events

Recall of Device Recall Medline RF Detect Sterile XRay Detectable USP Type VII Gauze

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    48749
  • Event Risk Class
    Class 2
  • Event Number
    Z-2321-2008
  • Event Initiated Date
    2008-06-13
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72056
  • 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
    There is the potential for the rf id tag to separate from the retaining pouch.
  • Action
    Initially a recall letter dated 6/13/08 was sent to the direct accounts identifying 5 lots of affected lots with two reorder numbers involved, explaining that there was a lack of integrity of the retaining pouch material for the RFID gauze, and that there was a potential for the RFID tag to separate from the retaining pouch during use. It was subsequently discovered that there was only one reorder number affected by the problem and that an additional lot had been gamma sterilized. Therefore a second letter dated 6/19/08, listing the correct reorder number and the six affected lots, was sent via FedEx overnight on the same date. The accounts were requested to remove RFID gauzes with the listed lot numbers from all stock rooms, materials storage, and OR's, and return it to Medline for replacement. The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the amount and lot numbers of the gauzes being returned. Any questions were directed to 866-359-1704, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall. If you have questions about this recall, contact Kathy Dunne at 847-970-4678 or at kdunne@medline.com.

Device

Device Recall Medline RF Detect Sterile XRay Detectable USP Type VII Gauze
  • Model / Serial
    reorder: NON21432RF, lots CM130002052, CM130002062, CM130002075, CM130002068, CM130002079, and CM130002110
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington
  • Product Description
    Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA, Made in China; reorder: NON21432RF
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA