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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Avanos Medical, Inc.: 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.

Agency Publication Date: March 13, 2023
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Affected Products

Product: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).

Lot Numbers:
Number
Product: BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.

All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91663
Status: Resolved
Manufacturer: Avanos Medical, Inc.
Manufactured In: United States
Units Affected: 2 products (780 units; 220 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.