Recall Z-0770-2019— LivaNova USA

Name: FDA recall Z-0770-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Class II · Terminated

Class II FDA medical device recall by LivaNova USA, initiated 2018-11-09, terminated 2022-05-03. It names one FDA 510(k) clearance: K881330. Product: Perfusion Pack, Rx only, Sterile EO. Reason: 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded..

Recalling firm: LivaNova USA
Classification: Class II
Status: Terminated
Initiated: 2018-11-09
Terminated: 2022-05-03
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K881330 — COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACKCobe Laboratories, Inc.·cleared 1988-06-10

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

Perfusion Pack, Rx only, Sterile EO

Reason for recall

4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.

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