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

Recall Z-2177-2012 — System 1 base 100/120V The Terumo Advanced Perfusion System 1 is 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 si

U.S. FDA — Device Enforcement · United States · 2012-07-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2177-2012
Date of alert: 2012-07-26
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 sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re

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

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