| Date Initiated by Firm | November 16, 2000 |
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| Date Posted | October 15, 2003 |
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| Recall Status1 |
Terminated 3 on May 03, 2012 |
| Recall Number | Z-0013-04 |
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| Recall Event ID |
26278 |
| 510(K)Number | K925542 |
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| Product | Critikon brand Omni-Stat Finger Sensor - P/N 009084 |
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| Code Information |
Lot 006 |
Recalling Firm/
Manufacturer |
GE Medical Systems Information Technologies
4502 Woodland Corporate Blvd.
Tampa FL 33614
|
| For Additional Information Contact | Thomas English
813-887-2000 |
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Manufacturer Reason
for Recall | Instructions for use contained incorrect sensor reference. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | Total of 481 |
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| 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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| 510(K) Database | 510(K)s with Product Code =
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