pCO2 D788 Membranes — Class II medical device recall Z-1075-2014
Terminated recall by Radiometer America Inc, reported 2014-03-05, distributed nationwide. RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient resu
| Recall number | Z-1075-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2013-07-05 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA |
| Lot numbers | R338, R493 |
| Model numbers | 942-063 |
Product
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
Reason for recall
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
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-1075-2014. 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.