FDA recall Z-1522-2025

Avanos Medical, Inc. · Class I · device

Product

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A

Reason for recall

Lack of sterility assurance for closed suction catheter systems

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.

Key facts

Status
Ongoing
Initiation date
2025-03-19
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2025