FDA-Device2018-02-28Class III
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.
LivaNova USA
Hazard
The product is labeled with the incorrect expiration date.
Sold states
Distribution was made to one consignee in LA.
Affected count
16 units (6 from lot 1717800062 and 10 units from lot 1720800071
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2018Don't want to check this manually?
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