FDA Medical Device Recalls (openFDA)
Beaver-Visitec International Inc.: BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
- Recall number
- Z-1805-2015
- Recalling firm
- Beaver-Visitec International Inc.
- Product
- BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
- Status
- Terminated
- Initiated
- 2015-05-01
- Posted
- 2015-06-15
- Terminated
- 2021-01-28
- Reason
- Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
- Root cause
- Nonconforming Material/Component
- Action
- Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950.
- Quantity
- 214 kits
- Distribution
- Nationwide Distribution including KY, GA, MI, and NJ.
- Lot, serial or model codes
- Lot Numbers: 3045852 3053258 3063193 3068829
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28