Device 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.
Z-1192-2013
Product summary
- Event
- Event 64919
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4298.5 cases
- Official record key
device-enforcement:Z-1192-2013
Official wording
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.
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.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
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.