Z-0664-2018 Class III Terminated
FDA device recall Z-0664-2018 was initiated by LivaNova USA on December 19, 2017 and is designated Class III. Reason for recall: The product is labeled with the incorrect expiration date. The recall status is terminated (terminated August 11, 2020). Affected quantity: 16 units (6 from lot 1717800062 and 10 units from lot 1720800071.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- December 19, 2017
- Termination Date
- August 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
Product Description
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.
Reason for Recall
The product is labeled with the incorrect expiration date.
Distribution Pattern
Distribution was made to one consignee in LA.
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