Recall Z-0664-2018— LivaNova USA

Name: FDA recall Z-0664-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-19

Class III · Terminated

Class III FDA medical device recall by LivaNova USA, initiated 2017-12-19, terminated 2020-08-11. It names one FDA 510(k) clearance: K981613. 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: The product is labeled with the incorrect expiration date..

Recalling firm: LivaNova USA
Classification: Class III
Status: Terminated
Initiated: 2017-12-19
Terminated: 2020-08-11
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K981613 — COBE SMARXT TUBING AND CONNECTORSCobe Cardiovascular, Inc.·cleared 1998-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.