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.
FDA Recall Z-2417-2015 · Posted 2015-08-19
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeLKD
Date Initiated2015-07-16
Date Terminated2016-01-29
Product Quantity4244 kits
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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, Hungry, United Arab Emirates, Poland, Colombia, Belgium and Malta.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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