Device product
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Z-0664-2018
Product summary
- Firm
- LivaNova USA
- Event
- Event 79000
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
- Official record key
device-enforcement:Z-0664-2018
Official wording
Reason: The product is labeled with the incorrect expiration date.
Code information: Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Distribution pattern: Distribution was made to one consignee in LA.
Derived failure modes
-
Unknown
The product is labeled with the incorrect expiration date.