Class 1 Device Recall BALLARD ACCESS Closed Suction System Neonates/Pediatrics

• Date Initiated by Firm: February 03, 2023
• Date Posted: March 13, 2023
• Recall Status: Terminated on September 05, 2024
• Recall Number: Z-1189-2023
• Recall Event ID: 91663
• Product Classification: Catheters, suction, tracheobronchial - Product Code BSY
• Product: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
• Code Information: All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
• Recalling Firm/ Manufacturer: Avanos Medical, Inc.; 5405 Windward Pkwy; Alpharetta GA 30004-3894
• For Additional Information Contact: 470-448-5591
• Manufacturer Reason for Recall: Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
• FDA Determined Cause: Component design/selection
• Action: Avanos hand-delivered the recall notification to the single consignee on 02/03/2023. The letter instructed the customer to discontinue use of and quarantine their stock of all lots of affected units and return them. Additionally, the customer was instructed to complete and return the acknowledgement form.
• Quantity in Commerce: 780 units
• Distribution: US Nationwide distribution in the state of Oklahoma.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.