PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 28, 2014 Initiated: May 9, 2014 #Z-1634-2014

Product Description

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

Details

Units Affected
1
Distribution
one customer in IA
Location
Ann Arbor, MI

Frequently Asked Questions

What product was recalled?
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535). Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 1.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 28, 2014. Severity: Moderate. Recall number: Z-1634-2014.