Recall Z-1192-2013— Owens & Minor Distribution, Inc.
Class II · Terminated
Class II FDA medical device recall by Owens & Minor Distribution, Inc., initiated 2013-03-26, terminated 2014-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Owens & Minor Distribution, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-26
- Terminated
- 2014-10-31
- Firm location
- Mechanicsville, VA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.