[pending] Halyard, Pain Pack. Kit Code: AMPK48-01.
Pending LLM rewrite. Source: FDA_DEVICE Z-2407-2026.
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
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
The recalled product
- Product
- Halyard, Pain Pack. Kit Code: AMPK48-01.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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