Radiometer America Inc D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
Type D826, Accessory Kit Part Number: 904-308. Lot Codes R0172 through R0223, inclusive.
Products Sold
Type D826, Accessory Kit Part Number: 904-308. Lot Codes R0172 through R0223, inclusive.
Radiometer America Inc is recalling D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutan due to Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI
Page updated: Jan 10, 2026