Critikon brand Omni-Stat Finger Sensor - P/N 009084
This recall has been terminated (originally issued October 15, 2003).
- Recall Initiated
- November 16, 2000
- Posted
- October 15, 2003
- Terminated
- May 3, 2012
- Recall Number
- Z-0013-04
- Quantity
- Total of 481
- Firm Location
- Tampa, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Instructions for use contained incorrect sensor reference.
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 singapore.
Lot / Code Info
Lot 006
Root Cause
Other
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.
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