Home/Recalls/FDA-Z-2798-2026
FDA DevicesClass I

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

Published: August 12, 2026Recall ID: Z-2798-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

Recalling Firm: AVID Medical, Inc.

Reason for Recall / 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.

Product Description & Identification

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

Affected Products

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

Additional Source Details

FieldValue
CityToano
StateVA
Event id99339
Address 19000 Westmont Dr
Code infoUDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950
Postal code23168-9351
Report date20260812
Product typeDevices
Product quantity5168 kits
Reason for recallAffected 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260430
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260731

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Overview

  • Recalling FirmAVID Medical, Inc.
  • StatusOngoing
  • Risk LevelClass I
  • DistributionUS Nationwide distribution in the states of NC and TX.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: AVID Medical, Inc. - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

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