FDAHealthAugust 4, 2025
AVID Medical, Inc. — Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
⚠️ Potential for open header bag seals, compromising sterility.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 4, 2025
US Nationwide distribution in the state of Florida.
What's affected?
- Product
- Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- 1647218
Additional details
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 57 units.
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