Recall Z-2417-2015— Radiometer America Inc
Class II · Terminated
Class II FDA medical device recall by Radiometer America Inc, initiated 2015-07-16, terminated 2016-01-29. It names one FDA 510(k) clearance: K093154. Product: 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 (tcpO2) partial pressures.. 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..
- Recalling firm
- Radiometer America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-16
- Terminated
- 2016-01-29
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 (tcpO2) partial pressures.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.