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Moderate riskFDA DeviceClass II

Halyard arteriogram kit recalled for incomplete header bag seal

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.

From the FDA notice · Read the official notice ↗ · All AVID Medical recalls

What to do

  1. Stop using affected kits immediately if you have them in stock.
  2. Check your inventory for Catalog Number EUHM009-01, Lot 1635477 (expiration 5/29/2028).
  3. Contact your supplier or AVID Medical for instructions on return or replacement.
  4. If you already used a kit from this lot, contact your medical device representative or local health authority.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Sold in
US distribution to GA, IL, NE, MD.
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
300 units
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class II
Recall number
Z-0928-2026

In the FDA's words

Description
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. Potential for incomplete seal on header bag. Catalog Number: EUHM009-01. UDI-DI: 10809160346839. Lot Number: 1635477. Expiration Date: 5/29/2028. Distribution: US distribution to GA, IL, NE, MD. Affected quantity: 300 units
Hazard
Potential for incomplete seal on header bag.

5 products in this recall

Halyard surgical packs recalled for incomplete packaging seal

AVID Medical is recalling five Halyard procedure packs because the header bag may not be fully sealed. The recall includes 728 units distributed in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from AVID Medical

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Related topics

SterilityMedical devicesGAILMDNEMore from FDA Device