Home / Recalls / LivaNova USA / Z-0664-2018

Z-0664-2018 Class III Terminated

Recalled by LivaNova USA — Arvada, CO

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

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