Class 2 Device Recall Critikon

• Date Initiated by Firm: November 16, 2000
• Date Posted: October 15, 2003
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0014-04
• Recall Event ID: 26278
• Product: Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
• Code Information: Lot numbers 008 and 005
• Recalling Firm/ Manufacturer: GE Medical Systems Information Technologies; 4502 Woodland Corporate Blvd.; Tampa FL 33614
• For Additional Information Contact: Thomas English; 813-887-2000
• Manufacturer Reason for Recall: Instructions for use contained incorrect sensor reference.
• FDA Determined Cause: 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.

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.