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 VPS Rhythm ECG Accessory Packs because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 35 other countries.
Arrow International Inc 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.
Arrow International is recalling 5Fr Catheter Clamps with Fasteners because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.
Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise product sterility.
Arrow International Inc is recalling MAC Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 Echogenic Introducer Needles because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 PSI kits because unsealed packaging may have compromised sterility. The recall covers products distributed in the US and 34 other countries.
Arrow International Inc is recalling 416,055 Clear Fenestrated Drapes with Adhesive because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 PICC catheters because unsealed packaging may have compromised product sterility.
Arrow International is recalling 416,055 catheter hemostasis valves because unsealed packaging may compromise product sterility.
Arrow International Inc is recalling 416,055 ARROWgard Blue PLUS Multi-Lumen CVC Kits because unsealed packaging may compromise product sterility.
Arrow International Inc is recalling 0.2 Micron Flat Epidural Filters 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 Inc is recalling 416,055 Multi-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 VPS TipTracker Stylet Accessories because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling ARROWg+ard Blue Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 continuous nerve block needles 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 central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International is recalling SnapLock Catheter/Syringe Adapters because unsealed packaging may compromise sterility. The recall affects 416,055 units distributed in the US and 34 other countries.
Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes because unsealed packaging may compromise product sterility.
Arrow International is recalling 416,055 central venous catheter kits because unsealed packaging may compromise product sterility.