FDA Device recall Z-1634-2014
CDI Blood Parameter Monitoring System
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of CDI Blood Parameter Monitoring System by Terumo Cardiovascular Systems, citing 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 He….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1634-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-09 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | IA |
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
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
Identifiers
| code_info | Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1634-2014%22
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