FDA (Devices) recall action 80169
The FDA (Devices) publishes a recall like this one as 38 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 38 pages.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
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.
Angiodynamics Inc. is recalling 13 boxes of RS Tandem 5F DL Xcela PICC catheters because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling Xcela 5FDL-55cm Maximal Barrier Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling TANDEM 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 5F DL BIOFLO PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 27 boxes of CAN 5F Dual Xcela PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling RS 5F DL XCELA PICC kits because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 298 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling RS Tandem 5F DL Bioflo Pasv catheters because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 17 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 20 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling RS 5F DL XPP kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 36 boxes of 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 12 boxes of RS 5F DL BIOFLO PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 7 units of RS TANDEM 5F DL XPP kits because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 5 boxes of RS 5F DL XPP Kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 104 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling BioFlo PICC Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.