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U.S. Department of Health and Human Services

Class 2 Device Recall MediChoice Rayon Tipped OB/GYN Applicator

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  Class 2 Device Recall MediChoice Rayon Tipped OB/GYN Applicator see related information
Date Initiated by Firm March 26, 2013
Date Posted May 01, 2013
Recall Status1 Terminated 3 on October 31, 2014
Recall Number Z-1192-2013
Recall Event ID 64919
Product Classification Applicator, absorbent tipped, non-sterile - Product Code KXF
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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Owens & Minor Distribution, Inc.
9120 Lockwood Blvd
Mechanicsville VA 23116-2015
For Additional Information Contact
804-723-7802
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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