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

Recall Z-1734-2013 — CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. 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.

U.S. FDA — Device Enforcement · United States · 2013-02-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1734-2013
Date of alert: 2013-02-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo Cardiovascular Systems Corporation
Product category: device
Product type: Devices

Reported risk: Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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