Avanos Medical, Inc. Recall 96528
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
Avanos Medical, Inc. Recall 96528 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1528-2025 |
| Event ID | 96528 |
| Event 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 |
| Product Type | Devices |
| 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. |
| Recall Reason | Lack of sterility assurance for closed suction catheter systems |
| Device Classification | 20250423 |
| Device Code Info | Lot Code: Lot/ Serial Number(s): 1555426 Each: 00609038982649 DSP: 10609038982646 Case: 20609038982643 |
| Center Classification Date | 20250416 |
| Recall Initiation Date | 20250319 |
| Recalling Firm | Avanos Medical, Inc. |
| Initial Notification | |
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