FDAJuly 16, 2015device

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 s...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

radiometer americaradiometer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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