Davol, Inc.: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Davol, Inc.
- Product
- Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
- Reason / hazard
- Potential for product to contain foreign matter, confirmed to be inspect fragments.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of China, South Korea.
- Recall initiated
- 2026-03-25
- Code info
- Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
- Product quantity
- 1,622 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warwick
- State
- RI
- Country
- United States
- Event id
- 98602
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