Z-1119-2020 Class III Terminated
FDA device recall Z-1119-2020 was initiated by LivaNova USA Inc. on January 28, 2019 and is designated Class III. 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 recall status is terminated (terminated January 31, 2022). Affected quantity: 5 Datapads.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- January 28, 2019
- Termination Date
- January 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 Datapads
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.
Distribution Pattern
US: NJ and CA
Code Information
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