Radiometer Fixation Kit N20 Recalled for Paper Coating Transfer
Radiometer America Inc is recalling Fixation Kit N20 units because paper liner coating may stick to the fixation ring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential cosmetic or functional defect (coating transfer) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Radiometer America Inc is recalling 4,244 units of the Radiometer Fixation Kit N20 (REF 905-873) for the TCM CombiM monitoring system. The recall is due to a potential issue where fractions of the paper liner's surface coating may stick to the surface of the fixation ring when the ring is removed from the liner.
The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. These sensors are used with the TCM CombiM monitoring system and the Philips TcG10 module for continuous transcutaneous monitoring of carbon dioxide and oxygen partial pressures. The affected lots include 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, and 505181.
The affected products were distributed worldwide, including in the United States, 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, Hungary, United Arab Emirates, Poland, Colombia, and Malta. Users should check their lot numbers against the list provided and contact Radiometer America Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 4,244
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model #: 905-873 Lots: 407221
- 407231
- 407241
- 407251
- 408041
- 408191
- 408201
- 408211
- 408231
- 408232
- 408261
- 408271
- 409021
- 409101
- 409231
- 409291
- 410021
- 410141
- 410281
- 411171
Distribution
Distribution scope not specified by the agency.
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