Avitene Ultrafoam Microfibrillar Collagen Hemostat Recalled for Foreign Matter
Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog Number 1050030) because the product may contain foreign matter, confirmed to be inspect fragments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a surgical hemostat with confirmed foreign matter contamination, which presents a risk of harm in a surgical/medical context. The source text states no illnesses or injuries have been reported, but the presence of foreign matter in a medical device used during surgical procedures poses a potential risk to patient safety.
Plain-English summary
Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat, size 8cm x 6.25cm x 1cm (Catalog Number 1050030), due to the potential for the product to contain foreign matter, confirmed to be inspect fragments.
A total of 1,622 units have been distributed worldwide, including to the United States and the countries of China and South Korea. The affected lot is Lot Number WBJS0055 with an expiration date of July 28, 2027. The product is identified by UDI (01)00801741010538(17)270728(10)WBJS0055.
Consumers and healthcare providers who have this product should stop using it immediately and contact Davol, Inc. for instructions on return or disposal. Anyone with questions should reach out to the manufacturer.
The recalled product
- Product
- Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
- Manufacturer
- Davol, Inc.
- Affected units
- 1,622
Distribution
Distributed nationwide across the United States.
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