FDA-Device2023-03-22Class I
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
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-1189-2023More Avanos Medical, Inc. recalls
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit 24 Fr recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit with ENFit Connector recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos MIC Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection
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