Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software ...
FDA Recall #Z-1521-2025 — Class I — March 19, 2025
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
Recalling Firm
Avanos Medical, Inc. — Alpharetta, GA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1980 units
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.
Code Information
Lot Code: Lot/ Serial Number(s): 1561168 Each: 00609038938264 DSP: 10609038938261 Case: 20609038938268
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated