FDA (Devices) recall action 79197
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
These finished good kits may contain the incorrect Springwire Guide (SWG).
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.
Arrow International is recalling 5,926 central venous catheterization kits because they may contain the incorrect Springwire Guide.
Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide because they may contain the incorrect Springwire Guide.
Arrow International Inc. is recalling 5,926 ARROWg+ard Blue Plus Multi Lumen CVC kits that may contain the incorrect Springwire Guide.
Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.
Arrow International Inc is recalling 5,926 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Arrow International Inc. is recalling 5,926 Arrow Multi Lumen CVC Kits because they may contain the incorrect Springwire Guide.
Arrow International Inc is recalling specific lots of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kits because they may contain the incorrect Springwire Guide.
Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide because they may contain the incorrect Springwire Guide.
Arrow International Inc is recalling 5,926 central venous catheterization kits because they may contain the incorrect Springwire Guide.
Arrow International is recalling specific lots of ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.