Recall Z-1436-06 ยท KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Radiometer America Inc
D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)
| Date | Aug 31, 2006 (initiated Nov 1, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001866 | TCM400 Radiometer Medical A/S, Dec 7, 2000 |