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Recall Observatory FDA recall evidence

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

March 26, 2013

Class II

Product summary

Firm
Owens & Minor Distribution, Inc.
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

    reason.no_named_rule · v1.0.0

    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.