Recall Z-1189-2023— Avanos Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Avanos Medical, Inc., initiated 2023-02-03, terminated 2024-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.. 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..
- Recalling firm
- Avanos Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2023-02-03
- Terminated
- 2024-09-05
- Firm location
- Alpharetta, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.