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Avanos Medical, Inc. recalls BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Recalled March 22, 2023 · FDA recall Z-1189-2023 · Avanos Medical
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. · FDA Class I
Units
780 units
Sold at
US Nationwide distribution in the state of Oklahoma.
Description
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.
Product
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Manufacturer(s)
Avanos Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →