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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall BALLARD ACCESS Closed Suction System Neonates/Pediatrics see related information
Date Initiated by Firm February 03, 2023
Date Posted March 13, 2023
Recall Status1 Completed
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 2		 Under Investigation by firm
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.
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