CDI Blood Parameter Monitoring System — Class II medical device recall Z-1634-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-05-28, distributed in IA. There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respira
| Recall number | Z-1634-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2014-05-09 |
| Classified | 2014-05-19 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-07-11 |
| Distributed | IA |
| Quantity | 1 |
| Serial numbers | 8015552, B015552 |
| Model numbers | 145891, 500AVHCT |
Product
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Reason for recall
There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep
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-1634-2014. 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.