Z-1192-2013Class II

MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and...

Name: Z-1192-2013 MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and...
Creator: Owens & Minor Distribution, Inc.
Published: 2013-03-26
License: https://open.fda.gov/license/

Owens & Minor Distribution, Inc. / initiated 2013-03-26 / Terminated

FDA source

Owens & Minor Distribution, Inc. began a recall of MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped... on 2013-03-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1192-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-26
Posted: 2013-05-01
Terminated: 2014-10-31
Recalling firm: Owens & Minor Distribution, Inc.
Product: 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.
Product code: KXF Applicator, Absorbent Tipped, Non-Sterile
Reason for recall: 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.
FDA root cause: Process change control
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.
Quantity in commerce: 4298.5 cases
Distribution: US Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1192-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1192-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-30

Product code KXF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)