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

Recall Z-0129-2013 — Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualifi

U.S. FDA — Device Enforcement · United States · 2012-09-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0129-2013
Date of alert: 2012-09-25
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 (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction

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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