LivaNova USA recalls Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is…

Recall date

December 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0664-2018

FDA classification

Class III

Brand / firm

LivaNova USA

Sold / distributed

Distribution was made to one consignee in LA.

Why it was recalled

The product is labeled with the incorrect expiration date.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.