FDA (Devices) recall action 79890
The FDA (Devices) publishes a recall like this one as 76 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 76 pages.
Product sterility may be compromised due to unsealed packaging.
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 Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 PICC Catheter Trimmers because unsealed packaging may compromise product sterility. The recall covers units distributed in the US and 34 other countries.
Arrow International is recalling specific central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling TheraCath Epidural Catheters because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
Arrow International Inc. is recalling 416,055 Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International is recalling Radial Arterial Access Kits because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
Arrow International Inc. is recalling Arterial Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 ECG adapters because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 ARROWgard Blue PLUS Triple-Lumen CVC Kits because unsealed packaging may compromise sterility.
Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 units of Peel Away Sheath over Dilator because unsealed packaging may compromise product sterility.
Arrow International Inc is recalling 416,055 units of 9 Fr. Radiopaque Polyurethane Sheath/Dilator because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International Inc is recalling 416,055 ARROW PICC Sets because unsealed packaging may compromise product sterility.
Arrow International is recalling Spring Wire Guide Introducer Needles because unsealed packaging may compromise product sterility.
Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.