Home / Recalls / Radiometer America Inc / Z-2417-2015

Z-2417-2015 Class II Terminated

Recalled by Radiometer America Inc — Brea, CA

FDA device recall Z-2417-2015 was initiated by Radiometer America Inc on July 16, 2015 and is designated Class II. 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. The recall status is terminated (terminated January 29, 2016). Affected quantity: 4244 kits.

Recall Details

Product Type
Devices
Report Date
August 26, 2015
Initiation Date
July 16, 2015
Termination Date
January 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4244 kits

Product Description

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.

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.

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.

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

Other recalls by Radiometer America Inc

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  • Z-0010-2019 Class II — ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Anal (May 25, 2018)
  • Z-0231-2018 Class II — ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of sa (October 24, 2017)
  • Z-3237-2017 Class II — AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas a (September 7, 2017)
  • Z-1462-2017 Class II — ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, (January 26, 2017)
  • Z-1463-2017 Class II — The ABL800 Model#:All (January 26, 2017)
  • Z-0899-2017 Class II — AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999 (November 23, 2016)
  • Z-0748-2016 Class II — AQURE System; Model Number: 933-599. The AQURE System manages blood gas and imm (December 29, 2015)

FDA data resources