FDA-Device2020-07-29Class III
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
LivaNova USA Inc.
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.
Sold states
Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
Affected count
140 units
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2642-2020Don't want to check this manually?
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