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
Reported: April 23, 2025 Initiated: March 19, 2025 #Z-1528-2025
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
Details
- Recalling Firm
- Avanos Medical, Inc.
- Units Affected
- 0
- 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: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A. Recalled by Avanos Medical, Inc.. Units affected: 0.
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-1528-2025.
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