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.
- Company
- Livanova Usa
- Recall Initiated
- December 19, 2017
- Terminated
- August 11, 2020
- Recall Number
- Z-0664-2018
- Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
- Firm Location
- Arvada, CO
Reason for Recall
The product is labeled with the incorrect expiration date.
Distribution
Distribution was made to one consignee in LA.
Lot / Code Info
Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Root Cause
Process control
Action Taken
The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
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