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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64919
Product Type Devices
Status Ongoing
Recalling Firm Owens & Minor Distribution, Inc.
City Mechanicsville
State VA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-26
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 4298.5 cases Z-1192-2013