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Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

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 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159
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-2796-2026
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