Owens & Minor Recalls MediChoice OB/GYN Applicators Due to Rayon Defect
Owens & Minor is withdrawing MediChoice OB/GYN applicators because the rayon tip may loosen or unravel during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that poses a risk of harm (material unraveling) during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Rayon Tipped OB/GYN Applicators, 8 inch, Plastic Shaft, Non-Sterile. The affected products are Item Numbers WOD5001 and WOD5002. The recall involves 4,298.5 cases distributed nationwide in the United States.
The withdrawal is being conducted because the products do not meet quality standards. Specifically, the rayon material may loosen or unravel from the applicator during use. The device is intended for medical purposes to apply medications or take specimens from a patient.
Consumers and healthcare facilities should stop using the affected applicators and contact Owens & Minor Distribution, Inc. for further instructions. Specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- 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
- Manufacturer
- Owens & Minor Distribution, Inc.
- Category
- Medical Device — Applicators
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 2017-06
- 2017-07
- 2017-08
- 2017-09
- 2017-10
- 2017-11
- 2018-02.
Distribution
Distributed nationwide across the United States.
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