The FDA today issued a notice labeling a recall by Avanos Medical (NYSE:AVNS) as Class I, the most serious kind.
Avanos’ recall regards its Ballard Access closed suction system for neonates and pediatrics. These affected devices feature the Y-manifold or elbow manifold. Avanos reported four injuries and one death related to the issue with the device.
Alpharetta, Georgia–based Avanos distributed affected devices between Oct. 20, 2022, and Jan. 23, 2023. To date, it recalled 1,000 devices in the U.S. since initiating the recall on Feb. 22, 2023.
The Ballard Access system provides access to the artificial airway of a child, infant or neonate without breaking the ventilation circuit. A single-patient-use device, it’s used only by trained medical professionals. The manifold holds indication for use together with the Ballard Access closed suction catheter. This combination removes secretions from the artificial airway of children, infants, and neonates.
Avanos initiated its recall due to customer complaints about cracked manifolds during use. A cracked manifold can cause leaks in the respiratory circuit. That may lead to the patient receiving inadequate ventilation, which can lead to serious brain damage or death. This rings especially true in the vulnerable patient population — children, infants and neonates — that receive care with this product.
The FDA noted that additional risks include the possibility of the introduction of a foreign body through the cracked manifold. That could cause infection, damage to the airway or a blocked endotracheal tube.
Avanos’ urgent medical device recall letter instructed users to quarantine all unused impacted products. For devices currently in use with patients, customers should check for cracks in the manifold. If they find a crack, they should replace devices with 24-hour use Ballard closed suction systems for neonates/pediatrics. These 24-hour products remain unaffected by the issue.
