Recall Z-1521-2025— Avanos Medical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Avanos Medical, Inc., initiated 2025-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No. Reason: Lack of sterility assurance for closed suction catheter systems.
- Recalling firm
- Avanos Medical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-03-19
- Firm location
- Alpharetta, GA, United States
Product description
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
Reason for recall
Lack of sterility assurance for closed suction catheter systems
Data sourced from openFDA. This site is unofficial and independent of the FDA.