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Serious riskFDA DeviceClass I

Halyard Cardiac Cath Pack kits recalled for particulate risk

Halyard Cardiac Cath Pack kits (EAMC1000-05) contain Medline Namic Angiographic Star Off Handle Manifolds that were recalled by the manufacturer. The manifolds may have particulates in their fluid path, which could enter the bloodstream and lodge in blood vessels. The recall covers 5,168 kits distributed nationwide, with the notice listing distribution in NC and TX.

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

What to do

  1. Set aside any Halyard Cardiac Cath Pack kits (EAMC1000-05) with the affected lot numbers listed in the notice.
  2. Check the UDI-DI 10809160377314 and lot numbers 1573593, 1583827, 1609541, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, or 1675159.
  3. Contact AVID Medical, Inc. for next steps, since the notice does not specify a remedy.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
Sold in
Nationwide
Made for
All ages (under 120 years)

This recall covers 3 products — see all of them.

Details

Units affected
5168 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class I
Recall number
Z-2796-2026

In the FDA's words

Description
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05 Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. UDI-DI 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159 Distribution: US Nationwide distribution in the states of NC and TX. Affected quantity: 5168 kits
Hazard
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

3 products in this recall

Halyard cath kits with Medline manifolds recalled for particulates

AVID Medical is recalling three Halyard convenience kits that contain Medline Namic Angiographic Star Off Handle Manifolds, which the manufacturer recalled because of particulates in the fluid path. The particulates could enter the bloodstream and become lodged in blood vessels. The notice lists about 5,168 affected kits for each of the three products, with distribution in the US, including NC and TX.

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

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