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Sorin Group Deutschland GmbH recalls S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be us
Recalled November 13, 2013 · FDA recall Z-0142-2014 · Sorin Group Deutschland
Hazard
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. · FDA Class II
Units
84
Sold at
Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
Description
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Product
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Manufacturer(s)
Sorin Group Deutschland GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →