Recall Z-2417-2015 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Radiometer America Inc
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (
| Date | Aug 19, 2015 (initiated Jul 16, 2015) |
| Status | Terminated |
| Reason | When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring. |
| Root cause | Under Investigation by firm |
| Action | Radiometer sent a Product Notification letter dated July 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In the letter the firm requests that inventory be checked and removed for any the identified lot numbers for Fixation kit N20. The firm requests that the products be discarded. The letter states to complete p.2 and return it to their Radiometer representative. If you have any questions contact Radiometer America Technical Support at 1-800-736-0600 opt.4. |
| Quantity | 4244 kits |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Canada, Spain, France, Great Britain, Philippines, Netherlands, Japan, China, Australia, Denmark, South Africa, Germany, Qatar, Turkey, Hong Kong, Costa Rica, Austria, Finland, Indonesia, Norway, Malaysia, Belgium, Czech Republic, Hu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM Radiometer Medical Aps, Feb 5, 2010 |