medical Class III Updated 2020-07-29

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
Lot/Code Info: Item# EC2135S, Lot No. 1923900091
View official government recall

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