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

Recall Z-2449-2012 — Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

U.S. FDA — Device Enforcement · United States · 2012-09-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2449-2012
Date of alert: 2012-09-20
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 Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat

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

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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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