BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
This recall has been terminated (originally issued March 13, 2023).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- February 3, 2023
- Posted
- March 13, 2023
- Terminated
- September 5, 2024
- Recall Number
- Z-1190-2023
- Quantity
- 220 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the state of Oklahoma.
Lot / Code Info
All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).
Root Cause
Component design/selection
Action Taken
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.