FDA-Device2026-10-22Class IIPACKAGING DEFECT
Halyard ANTERIOR HIP PACK (SOAH31) recalled for non-sterile component
What this means
Halyard ANTERIOR HIP PACK surgical kits (model SOAH31) contain a component that was not properly sterilized before packaging. The component was placed outside the sterile barrier and did not receive the required sterilization treatment. This affects 56 kits distributed in Arizona with lot number 1689215 and expiration date 11/06/2026.
- Check if you have this product by looking for model SOAH31 and lot number 1689215 on the packaging
- Do not use the affected kits for surgical procedures
- Contact your supplier or Halyard Medical for instructions on return or replacement
The agency's original wording
Hazard
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distributor in the state of Arizona.
Affected count
56 kits
Manufactured in
9000 Westmont Dr, Toano, Virginia, United States
Products
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2027More AVID Medical recalls
- FDA-Device2026-10-22Halyard ANTERIOR HIP PACK surgical kit recalled for non-sterile component
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