Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00636-1
Product Name/Description	Radiometer 905-873 Fixation Kit N20 (used with Radiometer TCM CombiM and Philips TC Gas10 for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures) Lot Numbers: 407221, 407241, 407251, 408201, 409231, 410021, 410141, 410281, 411171, 411201, 411261, 412111, 412201, 501081, 501131, 501191, 501311, 502031, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504081, 504111, 505041, 505141. ARTG Number: 165940
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/07/2015
Responsible Entity	Radiometer Pacific Pty Ltd
Reason/Issue	The Fixation Kit consists of an adhesive which is the interface to the patient’s skin and on the other side, a plastic ring with a sensor retainer mechanism, which allows fastening a tc Sensor 84 and tc Sensor 54. In some cases, when the operator detaches the fixation ring from the paper liner, fractions of the paper liner’s surface coating sticks to the adhesive surface of the ring. The result is a varying degree of adhesiveness of the ring to the skin. If the ring and sensor fall off, the displaying data on the monitor will not be in range and thus identified by the medical professional. If the sensor is only in partial contact with the patient’s skin it may result in an incorrect measurement.
Recall Action	Recall
Recall Action Instructions	Customers are advised to check inventory and stock in use for stock of the affected stock and discard them. Radiometer will provide free of charge replacement stock for stock that has been discarded. Users are advised to review customer results where affected stock was used and results were abnormal. This action has been closed-out on 15/08/2016.
Contact Information	1800 247 254 - Radiometer