Eagle Vision Inc began a recall of Krupin Eye Valve, P/N 6003 on . The reason FDA records is "Product may have deformed valves which would cause the valve not to operate properly". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0844-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Grace Medical, Inc.
- Product
- Krupin Eye Valve, P/N 6003
- Product code
- KYF Implant, Eye Valve
- Reason for recall
- Product may have deformed valves which would cause the valve not to operate properly.
- FDA 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 in commerce
- 94 units
- Distribution
- Nationwide, Canada, Columbia, Turkey, & The Netherlands
- Product codes and lots
- P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A
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