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U.S. Department of Health and Human Services

Class 2 Device Recall CDI Blood Parameter Monitoring System; CDI 500 Monitor

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 Class 2 Device Recall CDI Blood Parameter Monitoring System; CDI 500 Monitorsee related information
Date Initiated by FirmMay 09, 2014
Date PostedMay 19, 2014
Recall Status1 Terminated 3 on July 11, 2014
Recall NumberZ-1634-2014
Recall Event ID 68240
510(K)NumberK972962 
Product Classification Blood Parameter Monitoring System - Product Code DRY
ProductCDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Code Information Catalog Number or Part Number 145891 500AVHCT  Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer 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
FDA Determined
Cause 2		Release of Material/Component prior to receiving test results
ActionOn 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 Commerce1
Distributionone customer in IA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRY
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