Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Softwa...
FDA Recall #Z-1525-2025 — Class I — March 19, 2025
Product Description
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE 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
Product Quantity
2080 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): 1555424 Each: 00609038983103 DSP: 10609038983107 Case: 20609038983100
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated