Z-1634-2014Class II

CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers...

Name: Z-1634-2014 CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2014-05-09
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-05-09 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN... on 2014-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1634-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Posted: 2014-05-19
Terminated: 2014-07-11
Recalling firm: Terumo Cardiovascular Systems Corporation
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)
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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
Root cause tag: manufacturing process
FDA root cause: Release of Material/Component prior to receiving test results
Action: On 5/9/14, TCVS placed a phone call to the one affected customer regarding the recall. The phone call explained the reason for the recall, identification of affected product, potential hazard, and instructions for return of affected product.
Quantity in commerce: 1
Distribution: one customer in IA
Product codes and lots: Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1634-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1634-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-19

Product code DRY

K972962Class II3M Cdi Blood Parameter Monitoring System 5003M Company / cleared 1997-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)