[pending] Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Pending LLM rewrite. Source: FDA_DEVICE Z-0927-2026.
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
Potential for incomplete seal on header bag.
The recalled product
- Product
- Halyard, EP LAB PK. Catalog Number: ESJH009-03.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed in 4 states:
- GA
- IL
- MD
- NE
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