Krupin Eye Valve, P/N 6003
FDA device recall Z-0844-06 · posted 2006-05-06 · Terminated
Recall details
- Recalling firm
- Eagle Vision Inc
- Reason for recall
- Product may have deformed valves which would cause the valve not to operate properly.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KYF
- Quantity affected
- 94 units
- Distribution
- Nationwide, Canada, Columbia, Turkey, & The Netherlands
- Date initiated
- 2006-04-12
- Date posted
- 2006-05-06
- Date terminated
- 2006-09-13
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KRUPIN EYE VALVE WITH DISK (K905703) | Hood Laboratories | 1991-03-15 |