Recall Z-1119-2020— LivaNova USA Inc.
Class III · Terminated
Class III FDA medical device recall by LivaNova USA Inc., initiated 2019-01-28, terminated 2022-01-31. It names one FDA 510(k) clearance: K071318. 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..
- Recalling firm
- LivaNova USA Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-01-28
- Terminated
- 2022-01-31
- Firm location
- Arvada, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.