Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
FDA Recall Z-2796-2026 · Posted 2026-07-31
Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeOES
Date Initiated2026-04-30
Product Quantity5168 kits
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.
Firm Action
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
Distribution Pattern
US Nationwide distribution in the states of NC and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.