FDA Recall
Terminated
Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
Recall: Z-0015-04
·
Initiated November 16, 2000
Recall
- Recall Number
- Z-0015-04
- Event Number
- 26278
- Firm
- GE Medical Systems Information Technologies
- FEI Number
- 1030184
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 16, 2000
- Posted
- October 15, 2003
- Terminated
- May 3, 2012
- Address
- 4502 Woodland Corporate Blvd., Tampa, FL, 33614
Description
Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
Reason
Instructions for use contained incorrect sensor reference.
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.
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.
Quantity
Total of 481