Recall Weekly
Serious riskFDA DeviceClass I

Halyard heart cath kits recalled for particulate contamination

Halyard convenience kits contain Medline Namic Angiographic Star Off Handle Manifolds, which the manufacturer recalled because of particulates in the fluid path. The notice says particulate could enter the blood circulation and become lodged in blood vessels. The notice lists distribution in NC and TX.

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

What to do

  1. Set aside affected kits and do not use them.
  2. Check lot numbers against the 14 listed under UDI-DI 10809160408650.
  3. Contact AVID Medical, Inc. for instructions; 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. HEART CATH, SELF REGIONAL SELF131-05
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-2798-2026

In the FDA's words

Description
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05 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 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950 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.

More from AVID Medical

See all

Related topics

ParticulateMedical devicesSold nationwideMore from FDA Device