The FDA has identified Avanos Medical’s recall of certain airway access devices for children, infants, and neonates as a Class I recall, the most serious type, indicating use of these devices may cause serious injuries or death.
The recall applies to Avanos’ Ballard Access Closed Suction System for Neonates/Pediatrics featuring a Y-Manifold or Elbow Manifold (labeled 72-hour-use) distributed between October 20, 2022 and January 23, 2023. The company issued the recall Feb. 22, 2023 after receiving complaints from customers about cracked manifolds during use. A cracked manifold can cause leaks in the respiratory circuit, which may lead to the patient receiving inadequate ventilation.
Avanos has reported four injuries and one death related to this issue. The company has recalled 1,000 devices since it issued the recall.
Inadequate ventilation and oxygenation can lead to lead serious brain damage or death, especially in the vulnerable patient population (children, infants, and neonates) who receive care using this product. According to the FDA, additional risks from this issue include the possibility that a foreign body could be introduced through the cracked manifold, causing infection, damage to the airway, or a blocked endotracheal tube.
Avanos recommends the following:
- Check all storage and usage locations for impacted Ballard Access Closed Suction System for Neonates/Pediatrics with Y-Manifold or with Elbow Manifold (labeled “72 hour use”)
- Quarantine all unused impacted product.
For devices currently in use with patients, Avanos recommends the following:
- Check for cracks in manifold of any product currently in use with patients.
- Replace devices with cracked manifolds with a 24-hour use Ballard Closed Suction System for Neonates/Pediatrics (24-hour use products are unaffected by the reported issue).
- Use the 24-hour-use Ballard Closed Suction System for Neonates/Pediatrics for any new placements or scheduled placements.
- Complete and return the Acknowledgement Response Form included with the letter to [email protected], with the subject line: FCA-2023-002 Hospital Acknowledgement Response Form.
Customers with questions about this recall should email Avanos at [email protected].