Device product
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Z-1189-2023
Product summary
- Event
- Event 91663
- Status
- Terminated
- Classification
- Class I
- Quantity
- 780 units
- Official record key
device-enforcement:Z-1189-2023
Official wording
Reason: 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.
Code information: All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
Distribution pattern: US Nationwide distribution in the state of Oklahoma.
Derived failure modes
-
Unknown
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.