Recall Z-0664-2018
LivaNova USA · initiated December 19, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Reason for recall
The product is labeled with the incorrect expiration date.
FDA-determined cause: Process control
Action taken
The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
Details
- Recall number
- Z-0664-2018
- Initiated
- December 19, 2017
- Terminated
- August 11, 2020
- Product code
- DWE – Tubing, Pump, Cardiopulmonary Bypass
- Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
- Distribution
- Distribution was made to one consignee in LA.
- Recalling firm
- LivaNova USA, Arvada, CO