Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The fir...
FDA Recall #Z-0664-2018 — Class III — December 19, 2017
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.
Recalling Firm
LivaNova USA — Arvada, CO
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
16 units (6 from lot 1717800062 and 10 units from lot 1720800071
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated