Home / Recalls / LivaNova USA Inc. / Z-2642-2020

Z-2642-2020 Class III Terminated

Recalled by LivaNova USA Inc. — Arvada, CO

Recall Details

Product Type
Devices
Report Date
July 29, 2020
Initiation Date
November 18, 2019
Termination Date
August 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 units

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.

Distribution Pattern

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

Code Information

Item# EC2135S, Lot No. 1923900091

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