Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAM

FDA device recall Z-2797-2026 · posted 2026-07-31 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

Reason for recall

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.

Action taken

On April 30, 2026, firm notified distributors via email. Distributors were tasked with notifying their end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. They were provided with a labeling template to print warning labels which should be affixed on all affected kits and cases in inventory. The firm is also able to provide pre-printed labels if needed. Warning labels inform users to remove and discard the manifold prior to use.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OES

Quantity affected

5168 kits

Distribution

US Nationwide distribution in the states of NC and TX.

Date initiated

2026-04-30

Date posted

2026-07-31

Location

Toano, VA