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U.S. Department of Health and Human Services

Class 2 Device Recall transcutaneous pCO2 electrodes

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  Class 2 Device Recall transcutaneous pCO2 electrodes see related information
Date Initiated by Firm September 27, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on February 19, 2012
Recall Number Z-0341-2012
Recall Event ID 60153
510(K)Number K043003  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003.

Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
Code Information Part Number: 945-655, Lot Code: DP-06
Recalling Firm/
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1521
For Additional Information Contact James Gibbons
440-871-8900 Ext. 53489
Manufacturer Reason
for Recall
Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
FDA Determined
Cause 2
Employee error
Action Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.
Quantity in Commerce 4 units were distributed.
Distribution Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = LKD and Original Applicant = RADIOMETER MEDICAL APS