Inadequate Ventilation Risk Prompts FDA To Label Avanos Ballard Access Recall Class I

Avanos’ Ballard Access closed suction system for neonates and pediatrics has been issued a notice from the FDA labeling the product’s recall as Class I, which is the most serious kind. The faulty devices feature the Y- or elbow manifold, with the beleaguered Georgia-based company reporting four injuries and one fatality related to the flaw, and are said to have been distributed between October 20 of last and January 23, 2023. Since the initiation of the recall in late February, around 1,000 devices in the U.S. have been taken out of circulation.

The single-patient-use Ballard Access system, which is only meant to be used by trained medical professionals, gives access to the artificial airway of a child, infant, or neonate, and does so without breaking the ventilation circuit. Used together with the manifold, the Ballard Access closed suction catheter can take out secretions for the artificial airway. The recall kicked off when users began complaining about cracked manifolds during operation, which could lead to inadequate ventilation for an already vulnerable patient population of children, infants, and neonates.

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The urgent medical device recall letter penned by Avanos urged users to quarantine all unused impacted products, and instructed those with devices already in use to inspect theirs for cracks in the manifold. Those identifying a telltale crack have been told to replace devices with 24-hour use Ballard closed suction systems for neonates/pediatrics.