Recall Weekly
Serious riskFDA DeviceClass I

Halyard angiography kits recalled over particulate contamination

Halyard convenience kits that contain Medline Namic Angiographic Star Off Handle Manifolds are being recalled. The manifolds were recalled by the manufacturer because particulates were found in their fluid path, which could enter the bloodstream and become lodged in blood vessels. About 5,168 kits were distributed nationwide, with the affected kits sent to North Carolina and Texas, and no injuries have been reported.

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

What to do

  1. Check whether your facility has kits matching the listed UDI-DI 10809160388495 and the affected lot numbers.
  2. Set aside any affected kits and do not use them.
  3. Contact AVID Medical, Inc. for instructions on handling or returning the kits.
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. SAMMC ANGIOGRAPHY SAMM066-15
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
5168 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class I
Recall number
Z-2797-2026

In the FDA's words

Description
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15 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 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932 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.

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