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.
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. Distribution: US Nationwide distribution in the states of NC and TX. Quantity: 5168 kits Lot/code info: UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
10809160388495
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.