Reported Aug 26, 2015 · Terminated
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc…
Radiometer America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- 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.
- Lot codes and dates
- Model #: 905-873
- Lots
407221407231407241407251408041408191408201408211408231408232408261408271409021409101409231409291410021410141410281411171411201411261412021412111412161412201501081501131501191501311502031502101502131502171502231502261503091503231503311504031504081504111504271505041505061505141505181
- Amount recalled
- 4244 kits
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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