Krupin Eye Valve, P/N 6003
FDA Recall Z-0844-06 · Posted 2006-05-06
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Recalling FirmEagle Vision Inc
Recall StatusTerminated
Product CodeKYF
Date Initiated2006-04-12
Date Terminated2006-09-13
Product Quantity94 units
Reason for Recall
Product may have deformed valves which would cause the valve not to operate properly.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Canada, Columbia, Turkey, & The Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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