LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

Reason: Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.

Code information: Device Model, Catalog Number, Serial Number: SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0247 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0249 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0250 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0258 DATAPADIII WITHOUT SOFTWARE, 24-90-87, 17BQC0257

Distribution pattern: US: NJ and CA