FDA Medical Device Recalls (openFDA)
Eagle Vision Inc: Krupin Eye Valve, P/N 6003
- Recall number
- Z-0844-06
- Recalling firm
- Eagle Vision Inc
- Product
- Krupin Eye Valve, P/N 6003
- Status
- Terminated
- Initiated
- 2006-04-12
- Posted
- 2006-05-06
- Terminated
- 2006-09-13
- Reason
- Product may have deformed valves which would cause the valve not to operate properly.
- Root cause
- Other
- Action
- Written notification of the recall was sent out beginning 04/12/2006 to hospital administrators to advise them of the recall. The letter stated that implanting physicians were to be notified. A second updated notice was sent dated 04/19/2006 which contained more detailed information regarding the product problem.
- Quantity
- 94 units
- Distribution
- Nationwide, Canada, Columbia, Turkey, & The Netherlands
- Lot, serial or model codes
- P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A
- 510(k) numbers
- ["K905703"]
- PMA numbers
- not on file
- Product code
- KYF
- Firm FEI
- 1000022662
- Firm city
- Memphis
- Firm state
- TN
- 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