Recall Z-1523-2025 ยท BSY Catheters, Suction, Tracheobronchial
Avanos Medical, Inc.
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
| Date | Apr 16, 2025 (initiated Mar 19, 2025) |
| Status | Open, Classified |
| Reason | Lack of sterility assurance for closed suction catheter systems |
| Root cause | Under Investigation by firm |
| Action | 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 rem |
| Quantity | 9960 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.