Reported Nov 13, 2013 · Terminated
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used…
Sorin Group Deutschland GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin Group Deutschland GmbH · Lindberghstrasse 25 · Munchen, N/A · N/A
Is this the product you have?
S5 Heart-lung machineStockert S5 System
- Catalogue No48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less
- Lot codes and dates
- Serial Numbers
48E0023548E0033948E0034248E0175348E0276748E0275348E0274548E0274648E0274848E0241648E01033480E103848E0104048E0104148E0104348E0104448E0105148E0263148E0118348E0275848E0276448E0183248E0183448E0227848E0272248E0273248E0232648E0279748E0279348E0279148E0278148E0278548E0278648E0278348E0277248E0280248E0277848E0278448E0278848E0278948E0277948E0279248E0279048E0277148E0277348E0277648E0279948E02801
- Serial Numbers
- Amount recalled
- 84
Where it was sold
Why it was recalled
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
This product could cause temporary or reversible health problems — stop using it.
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