Recall Z-2642-2020— LivaNova USA Inc.

Name: FDA recall Z-2642-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-18

Class III · Terminated

Class III FDA medical device recall by LivaNova USA Inc., initiated 2019-11-18, terminated 2021-08-19. It names one FDA 510(k) clearance: K833322. Product: LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case. Reason: Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector..

Recalling firm: LivaNova USA Inc.
Classification: Class III
Status: Terminated
Initiated: 2019-11-18
Terminated: 2021-08-19
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K833322 — TUBING CONNECTORS EC-2XXX SERIESGish Biomedical, Inc.·cleared 1983-12-16

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 USA Sterile Disposable Connector,1/2x1/2, 20 units per case

Reason for recall

Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

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