Critikon brand Omni-Stat Finger Sensor - P/N 009084
FDA Recall Z-0013-04 · Posted 2003-10-15
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Recalling FirmGE Medical Systems Information Technologies
Recall StatusTerminated
Date Initiated2000-11-16
Date Terminated2012-05-03
Product QuantityTotal of 481
Reason for Recall
Instructions for use contained incorrect sensor reference.
Firm Action
A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
Root Cause
Other
Distribution Pattern
Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore.
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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