Avanos Ballard Infant Ventilator System Recall (2023): One Death Over Possible Leaks

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avanos ballard infant ventilator system recall



Avanos Medical Inc. announced the recall of around 1,000 units of Avanos BALLARD ACCESS Closed Suction System (labeled 72-hour-use) for Neonates/Pediatrics on February 22, 2023. The recall was issued over possible inadequate ventilation (due to leaks), including one reported death. (1)(2)

These medical devices are used to remove secretions from the artificial airway (such as a tracheostomy) of infants, neonates, and children. It’s used together with a BALLARD ACCESS Closed Suction catheter. (1)


Infant Ventilator System Recall 2023

Recall Details

On February 22, 2023, Avanos BALLARD ACCESS Closed Suction System devices (around 1,000 units) for Neonates/Pediatrics were recalled over possible leaks or cracks. These devices are primarily used in a hospital or healthcare setting. (1)(2)

The following models are affected: (1)

  • Y-Manifold
  • Elbow Manifold


Only the products labeled for 72-hour use are included in this recall. These items have been distributed from October 2022 to January 2023. (1)(2)

The company reportedly received four customer complaints about cracked manifolds. Cracks can lead to leaks in the respiratory circuit, making patients receive inadequate ventilation (oxygen). (1)

Some leaks may have been so severe that they led to serious outcomes, including possible brain damage and one death. (2)

Aside from receiving less oxygen, these vulnerable infants are also at risk of other problems, including potential infection caused by introducing pathogens (e.g., microbes) through these leaks. (1)(2)

The damaged products might also introduce broken fragments to the patient’s airways. This can affect the patient in two ways:

  • The fragments can block the endotracheal tube (a medical device used to deliver air to a patient’s lungs artificially; it’s attached through a procedure called “intubation”).
  • The fragments can also cause damage to the baby’s natural air tract. (1)(2)


What Infant Ventilator Systems Are Being Recalled?

Only these products are affected: (1)

  • BALLARD ACCESS Closed Suction System (labeled 72-hour use) for Neonates/Pediatrics with Y-Manifold
  • BALLARD ACCESS Closed Suction System (labeled 72-hour use) for Neonates/Pediatrics with Elbow Manifold


How Do I Check If My Infant Ventilator System Is Recalled?

Check the product label on the manifold’s plastic packaging. (1)

Only the products labeled “72-hour use” are affected by the recall. You can continue using those labeled for 24-hour use. (1)


What To Do With The Recalled Infant Ventilator Systems?

Carefully inspect the manifolds being used by the patient. Immediately replace them with products labeled for 24-hour use. Discard the used devices. (1)

“Quarantine” all unused impacted products and process your product replacement or refund. (1)

Registered customers will also receive a letter from the company informing them about the recall. (1)

Send an email to [email protected] with the filled-out “Acknowledgement Response Form” using the subject “FCA-2023-002 Hospital Acknowledgement Response Form.” (1)


Do I Need A Receipt For The Infant Ventilator System Recall?

  • Not indicated


Are These Infant Ventilator Systems Still Safe To Use?

No. The leaks or cracks might be too small to see but can cause serious issues, including brain damage or death, to a child using this device.


Where Are These Infant Ventilator Systems Made?

  • Not indicated


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