24

Jul

2013

Terumo CDI Blood Parameter Monitoring System Cl ll

0

Company: Terumo Cardiovascular Systems Corporation
Date of Enforcement Report: 7/24/2013
Class ll:

PRODUCT

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Recall Numbesr Z-1730-2013, Z-1731-2013, Z-1732-2013, Z-1733-2013, Z-1734-2013

REASON
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations

RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corporation, Ann Arbor, MI on 2/27/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3972 units since 4/26/12

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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