← Back to recalls

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

Class I
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.
Affected products (lot / model / serial)
UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950
Units affected
5168 kits
Distribution pattern
US Nationwide distribution in the states of NC and TX.
Firm location
Toano, VA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-2798-2026
Recall initiated
April 30, 2026
FDA classification date
July 31, 2026
FDA report date
August 12, 2026
FDA event ID
99339
Last updated on HTM Vibe
August 18, 2026
View on openFDA