[pending] Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1523-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lack of sterility assurance for closed suction catheter systems
The recalled product
- Product
- 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
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Lot/ Serial Number(s): 1555215
- 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315
Distribution
Distributed nationwide across the United States.
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