Date Initiated by Firm | November 16, 2000 |
Date Posted | October 15, 2003 |
Recall Status1 |
Terminated 3 on May 03, 2012 |
Recall Number | Z-0015-04 |
Recall Event ID |
26278 |
Product | Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136 |
Code Information |
Lot 3910 |
Recalling Firm/ Manufacturer |
GE Medical Systems Information Technologies 4502 Woodland Corporate Blvd. Tampa FL 33614
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For Additional Information Contact | Thomas English 813-887-2000 |
Manufacturer Reason for Recall | Instructions for use contained incorrect sensor reference. |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 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 singapore. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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