FDA (Devices) recall action 99339
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
AVID Medical, Inc. is recalling 5,168 Halyard convenience kits because they contain Medline Namic Angiographic Star Off Handle Manifolds that may have particulates in the fluid path.