Recall Z-1389-2020— LivaNova USA Inc.

Name: FDA recall Z-1389-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-03

Class III · Terminated

Class III FDA medical device recall by LivaNova USA Inc., initiated 2019-07-03, terminated 2021-07-09. It names one FDA 510(k) clearance: K981613. Product: LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.. Reason: Perfusion tubing pack was packaged with the incorrect cuvette..

Recalling firm: LivaNova USA Inc.
Classification: Class III
Status: Terminated
Initiated: 2019-07-03
Terminated: 2021-07-09
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

LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.

Reason for recall

Perfusion tubing pack was packaged with the incorrect cuvette.

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