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

Recall Z-0274-2013 — S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

U.S. FDA — Device Enforcement · United States · 2012-09-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0274-2013
Date of alert: 2012-09-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sorin Group USA, Inc.
Product category: device
Product type: Devices

Reported risk: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

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

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Recall Z-0274-2013 — S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

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