Events

Recall of Device Recall IUD INSERTION KIT 935K

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GYN Disposables 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
    59661
  • Event Risk Class
    Class 2
  • Event Number
    Z-3025-2011
  • Event Initiated Date
    2011-07-29
  • Event Date Posted
    2011-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103235
  • 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
    Uterine tenaculum. - Product Code HDC
  • Reason
    Lack of sterility assurance.
  • Action
    GYN Disposables Inc. sent out an "Urgent: Medical Device Recall" letter dated July 29, 2011 to all affected customers The letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included. For questions on this recall call (888) 372-2203, extension 101.

Device

Device Recall IUD INSERTION KIT 935K
  • Model / Serial
    Catalog Number: 935K. Lot number: 61034034.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, || GYN Disposables,Inc. || 2671 Appling Road, || Memphis, TN 38133, || ph 901.377.2200, || fx 901.377.2207 || Intended for intrauterine device (IUD) insertion.
  • Manufacturer
    GYN Disposables Inc

Manufacturer

GYN Disposables Inc
  • Manufacturer Address
    GYN Disposables Inc, 3150 Stage Post Dr Ste 103, Memphis TN 38133-4050
  • Manufacturer Parent Company (2017)
    Gyn Disposables Inc
  • Source
    USFDA