FDA-Device2023-03-22Class I
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Avanos Medical, Inc.
Hazard
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Sold states
US Nationwide distribution in the state of Oklahoma.
Affected count
780 units
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2023Don't want to check this manually?
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