FDA (Devices) recall action 77232
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.
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The agency’s own wording, quoted from the enforcement report.
Arrow International is recalling Two-Lumen Central Venous Access Kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International Inc is recalling ARROWg+ard Blue CVC Kits used for short-term central venous access. The recall affects 27,485 units distributed in the U.S. and 4,371 units internationally.
Arrow International is recalling single-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits under FDA Class II recall Z-2336-2017. The devices are used for short-term central venous access.
Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International is recalling specific hemodialysis catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International is recalling Pressure Injectable PICC Kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International is recalling Introducer Kits and Arrow PSI Kits because packaging may not be completely sealed, potentially compromising sterility.
Arrow International Inc. is recalling Arrow Pressure Injectable PICC Kits due to a Class II recall classification. The devices are used for intravenous therapy and blood sampling.
Arrow International is recalling Arterial Catheterization Kits because packaging defects may compromise sterility.
Arrow International is recalling specific central venous access kits because packaging may not be completely sealed, potentially compromising sterility.