Radiometer Fixation Kit N20 for the TCM CombiM monitoring system — Class II medical device recall Z-2417-2015
Terminated recall by Radiometer America Inc, reported 2015-08-26. When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's su
| Recall number | Z-2417-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2015-07-16 |
| Classified | 2015-08-19 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-01-29 |
| Countries outside the US | AE, AT, AU, BE, CA, CN, CO, CR, CZ, DE, DK, ES, FI, FR, GB, HK, ID, JP, MT, MY, NL, NO, PH, PL, QA, TR, ZA |
| Quantity | 4,244 kits |
| Lot numbers | 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 and 7 more |
| Model numbers | 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 and 23 more |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2417-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.