D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
This recall has been terminated (originally issued August 31, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- November 1, 2005
- Posted
- August 31, 2006
- Terminated
- April 25, 2012
- Recall Number
- Z-1436-06
- Quantity
- 3,323-USA, 1,197-Foreign
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
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
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 / Code Info
Type D826, Accessory Kit Part Number: 904-308. Lot Codes R0172 through R0223, inclusive.
Root Cause
Other
Action Taken
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.