Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
This recall is currently active, issued April 16, 2025. It was issued by Avanos Medical, Inc..
- Company
- Avanos Medical, Inc.
- Recall Initiated
- March 19, 2025
- Posted
- April 16, 2025
- Recall Number
- Z-1524-2025
- Quantity
- 9020 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of sterility assurance for closed suction catheter systems
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.
Lot / Code Info
Lot Code: Lot/ Serial Number(s): 1555453, 1564227 Each: 00609038944920 DSP: 10609038944927 Case: 20609038944924
Root Cause
Under Investigation by firm
Action Taken
On March 19, 2025, AirLife, legal manufacturer for Avanos issued a "Urgent Medical Device Recall" Notification to affected consignees via E-Mail. Avanos asked consignees to take the following actions: a. Review the list of affected products. Please examine your inventory for the mentioned lot(s). b. Immediately, stop/cease use and quarantine all affected product. c. Please complete and return the attached Response Form via e-mail to productquality@myairlife.com. d. if you have further distributed this product, please identify your customers/consignees, and notify them of this product removal. e. Once you return and/or confirm destruction of the affected product(s), new replacement product will be sent to you. If you need replacement products to be sent to you urgently, please call AirLife directly at 1-800-433-2797 and we will make every effort to accommodate your needs. f. Please make sure that all affected personnel in your organization are informed of this removal notice.