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Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

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 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
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-2797-2026
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