FDAFDA · Food and drugs·Recall number Z-1523-2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Published April 23, 2025 · Recall initiated: March 19, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance for closed suction catheter systems
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Avanos Medical, Inc.
- Distributor
- 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.
- Lot
- Lot Code: Lot/ Serial Number(s): 1555215, 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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