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LivaNova USA Inc. recalls LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Recalled July 29, 2020 · FDA recall Z-2642-2020 · LivaNova USA
Hazard
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. · FDA Class III
Units
140 units
Sold at
Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
Description
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.
Product
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Manufacturer(s)
LivaNova USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →