FDA recall Z-2642-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-11-18

Report date

2020-07-29

Termination date

2021-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2642-2020