LivaNova Sorin Connect DPIII KOMPL recalled over labeling errors

Recall date

January 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LivaNova USA Inc. recalls LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The…

Recall number

Z-1119-2020

FDA classification

Class III

Brand / firm

LivaNova USA Inc.

Sold / distributed

US: NJ and CA

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.