Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1634-2014 — CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

U.S. FDA — Device Enforcement · United States · 2014-05-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1634-2014
Date of alert: 2014-05-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo Cardiovascular Systems Corporation
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1634-2014 — CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

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