Halyard Pain Pack Kit recalled for unsterilized pouches
AVID Medical distributed 120 sealed Halyard Pain Pack kits (Kit Code AMPK48-01, Lot 334669) that did not undergo proper sterilization validation. The affected kits were distributed nationwide, with known distribution in Iowa. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All AVID Medical recalls
What to do
- Check if you have Halyard Pain Pack Kit Code AMPK48-01, Lot 334669 (Expiration 8/27/2028).
- Do not use affected kits.
- Contact your distributor or AVID Medical for instructions on return or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Halyard, Pain Pack. Kit Code: AMPK48-01.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 4 products — see all of them.
Details
- Units affected
- 120 kits
- Illnesses reported
- None reported
- Manufactured in
- 9000 Westmont Dr, N/A, Toano, VA, United States
- Classification
- Class II
- Recall number
- Z-2407-2026
In the FDA's words
- Description
- Halyard, Pain Pack. Kit Code: AMPK48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028. Distribution: US Nationwide distribution in the state of Iowa. Affected quantity: 120 kits
- Hazard
- Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
4 products in this recall
Halyard medical kits recalled for sterilization concerns
AVID Medical is recalling four Halyard kit types because sealed pouches were distributed without validated sterilization. The kits may not be sterile, and the recall includes 476 kits total, distributed in Iowa. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Halyard, Pain Pack. Kit Code: AMPK48-01. (this page)Z-2407-2026 · 120 kits
- Halyard, Towel Six Pack. Kit Code: AMTS70-01.Z-2408-2026 · 224 kits
- Halyard, Drape Pack. Kit Code: LMDP36-01.Z-2409-2026 · 72 kits
- Halyard, Eye Bag Pack. Kit Code: UIEB48-01.Z-2410-2026 · 60 kits
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