Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 So...
FDA Recall #Z-1528-2025 — Class I — March 19, 2025
Product Description
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
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
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): 1555426 Each: 00609038982649 DSP: 10609038982646 Case: 20609038982643
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated