Closed Suction System Manifold Cracking Poses Respiratory Circuit Leak Risk
Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of Severe. The defect—manifold cracking—can cause respiratory circuit leaks leading to inadequate ventilation in vulnerable neonatal and pediatric patients, though no illnesses or injuries have been reported.
Plain-English summary
Avanos Medical, Inc. is recalling 220 units of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. The recall covers all affected lots and stock codes as identified by the manufacturer.
The recalled device component can crack during use on patients. Cracking in the manifold can cause leaks in the respiratory circuit, potentially leading to inadequate ventilation.
The device is intended for neonatal and pediatric respiratory care. Patients relying on affected units may not receive adequate ventilation if manifold cracking occurs during treatment.
For more information about the recall, including affected lot numbers and stock codes, contact Avanos Medical, Inc. or the FDA's Medical Devices division.
The recalled product
- Product
- BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- manifold-cracking
- respiratory-leak
- ventilation-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All lots are affected. Stock Code (Lot Number): B50511 (20098277)
- B50611 (20098278)
- B50711 (20098279)
- B50811 (20097177
- 20097177R1).
Distribution
Distributed nationwide across the United States.
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