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U.S. Department of Health and Human Services

Class 2 Device Recall D826 accessory kit for tcpO2 electrodes

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  Class 2 Device Recall D826 accessory kit for tcpO2 electrodes see related information
Date Initiated by Firm November 01, 2005
Date Posted August 31, 2006
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-1436-06
Recall Event ID 35789
510(K)Number K001866  
Product Classification Cutaneous Oxygen Monitor - Product Code KLK
Product D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
Code Information Type D826, Accessory Kit Part Number: 904-308. Lot Codes R0172 through R0223, inclusive.
Recalling Firm/
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
Manufacturer Reason
for Recall
Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
FDA Determined
Cause 2
Action The firm decided to initiate a recall on 9/8/2005 and the recall letter was issued in November, 2005. The letter informs the customers of this problem and asks that each customer inspect their current stock for the presence of the recalled lot codes and discard any such product found. The letter is accompanied by a recall response form which the customer can use to request additional replacement ellectrodes as necessary.
Quantity in Commerce 3,323-USA, 1,197-Foreign
Distribution Worldwide distribution --- including the states of PA, IL, TX, NY, FL, KS, NE, AL, MI, LA, WI, MN, NJ, CA, NH, MD, OH, MO, UT, IN, GA, WA, MA, KY, NC, IA, OK, SD, CO, AR, SC, ME, NV, AZ, RI, AK, MS, VA, WV, MT, TN, IN & NM. Country List pending
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 = KLK and Original Applicant = RADIOMETER MEDICAL A/S