FDA-Device2025-12-24Class IIPACKAGING DEFECT
Halyard arteriogram kit recalled for incomplete header bag seal
What this means
AVID Medical is recalling Halyard arteriogram kits (Catalog Number EUHM009-01) because the header bag may not seal completely. This could allow the sterile contents inside to become contaminated. The recall affects 300 units distributed to hospitals in Georgia, Illinois, Nebraska, and Maryland.
- Stop using affected kits immediately if you have them in stock.
- Check your inventory for Catalog Number EUHM009-01, Lot 1635477 (expiration 5/29/2028).
- Contact your supplier or AVID Medical for instructions on return or replacement.
- If you already used a kit from this lot, contact your medical device representative or local health authority.
The agency's original wording
Hazard
Potential for incomplete seal on header bag.
Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to GA, IL, NE, MD.
Affected count
300 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2026More 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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