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Recall Observatory FDA recall evidence

Device 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.

Z-2417-2015

July 16, 2015

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 71739
Status
Terminated
Classification
Class II
Quantity
4244 kits
Official record key
device-enforcement:Z-2417-2015

Official wording

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.

Code information: Model #: 905-873 Lots: 407221, 407231, 407241, 407251, 408041, 408191, 408201, 408211, 408231, 408232, 408261, 408271, 409021, 409101, 409231, 409291, 410021, 410141, 410281, 411171, 411201, 411261, 412021, 412111, 412161, 412201, 501081, 501131, 501191, 501311, 502031, 502101, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504031, 504081, 504111, 504271, 505041, 505061, 505141, 505181

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.