MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product

FDA device recall Z-1192-2013 · posted 2013-05-01 · Terminated

Recall details

Recalling firm

Owens & Minor Distribution, Inc.

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.

Action taken

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.

Root cause

Process change control

Status

Terminated

Product code

KXF

Quantity affected

4298.5 cases

Distribution

US Nationwide Distribution.

Date initiated

2013-03-26

Date posted

2013-05-01

Date terminated

2014-10-31

Location

Mechanicsville, VA