Z-1523-2025 Class I Ongoing
FDA device recall Z-1523-2025 was initiated by Avanos Medical, Inc. on Mar 19, 2025 and is designated Class I. Reason for recall: Lack of sterility assurance for closed suction catheter systems The recall status is ongoing. Affected quantity: 9960 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 23, 2025
- Initiation Date
- Mar 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9960 units
Product Description
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
Reason for Recall
Lack of sterility assurance for closed suction catheter systems
Distribution Pattern
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): 1555215, 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315