FDA-Device2020-02-19Class III
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.
LivaNova USA Inc.
Hazard
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.
Sold states
US: NJ and CA
Affected count
5 Datapads
Manufactured in
14401 W 65th Way, Arvada, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2020Don't want to check this manually?
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