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.
Reported: February 19, 2020 Initiated: January 28, 2019 #Z-1119-2020
Product Description
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 for Recall
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.
Details
- Recalling Firm
- LivaNova USA Inc.
- Units Affected
- 5 Datapads
- Distribution
- US: NJ and CA
- Location
- Arvada, CO
Frequently Asked Questions
What product 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.. Recalled by LivaNova USA Inc.. Units affected: 5 Datapads.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Low. Recall number: Z-1119-2020.
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