Z-1525-2025 Class I Ongoing
FDA device recall Z-1525-2025 was initiated by Avanos Medical, Inc. on March 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: 2080 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2080 units
Product Description
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE 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): 1555424 Each: 00609038983103 DSP: 10609038983107 Case: 20609038983100