FDA recall Z-0664-2018

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.

Reason for recall

The product is labeled with the incorrect expiration date.

Distribution

Distribution was made to one consignee in LA.

Key facts

Status

Terminated

Initiation date

2017-12-19

Report date

2018-02-28

Termination date

2020-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2018