BALLARD ACCESS Closed Suction System for recall
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Why was BALLARD ACCESS Closed Suction System for recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
- Product
- BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 780 units
- Distribution
- US Nationwide distribution in the state of Oklahoma.
- Recall date
- March 22, 2023
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)