FDA-Device2013-11-13Class II
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.
Sorin Group Deutschland GmbH
Hazard
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Sold states
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.
Affected count
84
Manufactured in
Lindberghstrasse 25, N/A, Munchen, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2014Don't want to check this manually?
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