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
Reported: April 23, 2025 Initiated: March 19, 2025 #Z-1521-2025
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
Details
- Recalling Firm
- Avanos Medical, Inc.
- Units Affected
- 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.
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Avanos Medical, Inc.. Units affected: 1980 units.
Why was this product recalled? ▼
Lack of sterility assurance for closed suction catheter systems
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Critical. Recall number: Z-1521-2025.
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