FDA Medical Device Recalls (openFDA)
Radiometer America Inc: D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
- Recall number
- Z-1436-06
- Recalling firm
- Radiometer America Inc
- Product
- D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
- Status
- Terminated
- Initiated
- 2005-11-01
- Posted
- 2006-08-31
- Terminated
- 2012-04-25
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Type D826, Accessory Kit Part Number: 904-308. Lot Codes R0172 through R0223, inclusive.
- 510(k) numbers
- ["K001866"]
- PMA numbers
- not on file
- Product code
- KLK
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28