Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
FDA device recall Z-0015-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies
- Reason for recall
- Instructions for use contained incorrect sensor reference.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- Total of 481
- Distribution
- 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
- Date initiated
- 2000-11-16
- Date posted
- 2003-10-15
- Date terminated
- 2012-05-03
- Location
- Tampa, FL
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