Z-1436-06

D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous...

Name: Z-1436-06 D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous...
Creator: Radiometer America Inc
Published: 2005-11-01
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-11-01 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) on 2005-11-01. The reason FDA records is "Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1436-06
Status: Terminated
Initiated: 2005-11-01
Posted: 2006-08-31
Terminated: 2012-04-25
Recalling firm: Radiometer America, Inc
Product: D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
Product code: KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
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
Root cause tag: manufacturing process
FDA root cause: Other
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
Product codes and lots: Type D826, Accessory Kit Part Number: 904-308. Lot Codes R0172 through R0223, inclusive.

Product code KLK

K001866Class IITcm400Radiometer Medical A/S / cleared 2000-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)