FDA Device recall Z-1119-2020
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…
- FDA Device
- Class III
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class III recall of 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… by Livanova Usa, citing incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1119-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-28 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | CA, NJ |
Product
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.
Identifiers
| code_info | Device Model, Catalog Number, Serial Number: SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0247 SORIN CONNECT DPIII K…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1119-2020%22
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