LivaNova USA Inc. recalls LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

Recall date

November 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2642-2020

FDA classification

Class III

Brand / firm

LivaNova USA Inc.

Sold / distributed

Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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