Events

Recall of Device Recall MediChoice Rayon Tipped OB/GYN Applicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Owens & Minor Distribution, 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
    64919
  • Event Risk Class
    Class 2
  • Event Number
    Z-1192-2013
  • Event Initiated Date
    2013-03-26
  • Event Date Posted
    2013-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117406
  • 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
    Applicator, absorbent tipped, non-sterile - Product Code KXF
  • Reason
    Owens & minor distribution, inc. is conducting a market withdrawal of medichoice applicator ob-gyn 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.
  • Action
    Owens&Minor; sent an Urgent: Medical Device Recall letter to the first set of customers on March 26, 2013 and to their second set of customers on April 9, 2013. The letter identified the affect product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all affected products, contact service representative to discuss whether affected products should be returned or destroyed, and complete and return the Recall Reply Form. For questions call 804-723-7417.

Device

Device Recall MediChoice Rayon Tipped OB/GYN Applicator
  • Model / Serial
    Item # Lot#  WOD5001 1206DG13A  WOD5001 1206DG13B  WOD5001 1207DG13A  WOD5001 1208DG13A  WOD5001 1209DG13A  WOD5001 1210DG13A/B  WOD5001 1211DG13A  WOD5001 1212DG13A  WOD5001 1301DG13A  WOD5001 1303DG13A    WOD5002 1206DG14A  WOD5002 1208DG14A  WOD5002 1209DG14A  WOD5002 1211DG14A   Expiration Dates: 2017-05, 2017-06, 2017-06, 2017-07, 2017-08, 2017-09, 2017-10, 2017-11, 2018-02.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. || Product Usage: Usage: || An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
  • Manufacturer
    Owens & Minor Distribution, Inc.

Manufacturer

Owens & Minor Distribution, Inc.
  • Manufacturer Address
    Owens & Minor Distribution, Inc., 9120 Lockwood Blvd, Mechanicsville VA 23116-2015
  • Manufacturer Parent Company (2017)
    Owens & Minor Distribution, Inc.
  • Source
    USFDA