MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5...

FDA Device Recall #Z-1192-2013 — Class II — March 26, 2013

Recall Summary

Recall Number Z-1192-2013
Classification Class II — Moderate risk
Date Initiated March 26, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Owens & Minor Distribution, Inc.
Location Mechanicsville, VA
Product Type Devices
Quantity 4298.5 cases

Product Description

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.

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.

Distribution Pattern

US Nationwide Distribution.

Lot / 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.

Other Recalls from Owens & Minor Distribution, Inc.

Recall # Classification Product Date
Z-1059-2023 Class III FLUIDSHIELD 3 Fog-Free Procedure Mask with SO S... Jan 3, 2023
Z-0343-2023 Class II Aero Blue Performance Surgical Gown, XL- Steril... Oct 31, 2022
Z-0888-2017 Class II Medi Choice Arm Slings ASL 2103 Small 7.5 x ... Oct 31, 2016
Z-0734-2016 Class II MediChoice Cohesive Bandages, One (1) roll of c... Nov 17, 2015
Z-0733-2016 Class II MediChoice Cohesive Bandages, One (1) roll of c... Nov 17, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.