Avanos Medical Inc’s recall of certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics has raised concerns about the risk of inadequate ventilation and other injuries caused by cracked manifolds. This FDA Class I recall, the most severe type, emphasizes the potential for serious harm or even death associated with the use of these devices.
In the United States, a total of 1,000 devices have been recalled, with distribution occurring between October 20, 2022, and January 23, 2023. Avanos Medical initiated the recall on February 22, 2023. The recalled products are the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold and the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Elbow Manifold.
The purpose of the manifold in the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics is to provide access to the artificial airway of children, infants, and neonates without interrupting the ventilation circuit. These single-use devices are intended for use by trained medical professionals to remove secretions from the artificial airway of pediatric and neonatal patients.
The recall was prompted by customer complaints about cracked manifolds during device use. A cracked manifold can lead to leaks in the respiratory circuit, resulting in inadequate ventilation for the patient. The consequences of inadequate ventilation and oxygenation in the vulnerable pediatric and neonatal population are severe and can include brain damage or even death. Additionally, the cracked manifold poses the risk of introducing foreign bodies into the patient, potentially causing infection, airway damage, or blockage of the endotracheal tube.
For parents who tragically lost a child due to this recalled product, they may have the grounds to file a wrongful death product liability lawsuit. Filing a wrongful death lawsuit involves demonstrating that the manufacturer, Avanos Medical Inc. in this case, was responsible for the defect in the product that directly caused the death of the child. Consulting with an experienced wrongful death attorney who specializes in product liability cases is crucial for understanding the legal options available and pursuing justice for their loss.
To file a wrongful death product liability lawsuit, it is essential to gather evidence such as medical records, documentation related to the use of the device, and any available information regarding the defective manifold. An attorney will help in building a strong case by analyzing the circumstances, consulting with experts, and presenting a compelling argument against the manufacturer. They will also assist in documenting and calculating damages, which may include medical expenses, funeral costs, loss of companionship, and emotional distress.
It is important to note that wrongful death laws and statutes of limitations vary by jurisdiction. Therefore, seeking legal advice promptly is crucial to protecting one’s rights and ensuring the best possible outcome.
The recall of the BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics raises concerns about the risk of inadequate ventilation and other injuries due to cracked manifolds. For parents who have tragically lost a child as a result of this recalled product, pursuing a wrongful death product liability lawsuit may be an avenue for seeking justice. Consulting with an experienced attorney is vital to navigate the legal complexities, gathering evidence, and pursuing financial compensation for their devastating loss.
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