Avanos Medical, Inc. BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Brand
Avanos Medical, Inc.
Lot Codes / Batch Numbers
All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
Products Sold
All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
Avanos Medical, Inc. is recalling BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. due to Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receivin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026