Z-1189-2023 Class I Terminated
FDA device recall Z-1189-2023 was initiated by Avanos Medical, Inc. on February 3, 2023 and is designated Class I. 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. The recall status is terminated (terminated September 5, 2024). Affected quantity: 780 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- February 3, 2023
- Termination Date
- September 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 780 units
Product Description
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
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 Pattern
US Nationwide distribution in the state of Oklahoma.
Code Information
All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).