The US-based medical technology company is recalling its BALLARD ACCESS Closed Suction System for neonates and paediatrics distributed between 20 October 2022 and 23 January 2023
The US Food and Drug Administration (FDA) has classified the recall of certain BALLARD ACCESS Closed Suction System of Avanos Medical as Class I, which is the most serious type of recall as the use of these devices can cause serious injuries or death.
The US-based medical technology company is recalling its BALLARD ACCESS Closed Suction System for neonates and paediatrics distributed between 20 October 2022 and 23 January 2023. The device has the Y-manifold or elbow manifold (labelled for 72-hour use).
The BALLARD ACCESS Closed Suction System is designed to offer access to the artificial airway of a child, infant, or neonate, without breaking the ventilation circuit.
The BALLARD ACCESS Closed Suction manifold is intended for use with the BALLARD ACCESS Closed Suction catheter. The integrated solution aims to eliminate secretions from the artificial airway of children, infants, and neonates.
The move follows the complaints from customers about cracked manifolds during use. FDA said a cracked manifold can result in leaks in the respiratory circuit. It can lead to the patient receiving insufficient ventilation and oxygenation, which may result in serious brain damage or death.
According to the US health regulator, injury and death are possible, especially in vulnerable patient populations like children, infants, and neonates who get care using this product.
Additionally, some foreign bodies can enter via the cracked manifold and cause infection, damage to the airway, or block the endotracheal tube.
FDA said that Avanos recalled 1,000 devices in the US since starting the recall on 22 February 2023. The company has reported one death and four injuries related to this cracked manifold issue to date.
The medical technology company issued an urgent medical device recall letter to customers that instructed the customers to check all storage and usage locations for affected devices and quarantine all unused impacted products.
For devices currently in use with patients, Avanos has recommended checking for cracks in the manifold of any product and replacing them with a 24-hour use Ballard Closed Suction System for Neonates and Paediatrics, as they are unaffected by the reported issue.
The firm is reaching out to users to arrange for the product return, credit, and replacement once the acknowledgement form is submitted.