FDA-Device2026-06-17Class IIPROCESSING DEFECT
Halyard Pain Pack Kit recalled for unsterilized pouches
What this means
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.
- 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.
The agency's original wording
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Iowa.
Affected count
120 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard, Pain Pack. Kit Code: AMPK48-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2407-2026More AVID Medical recalls
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-09-09Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
- FDA-Device2026-07-29Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
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