FDA (Devices) recall action 79314
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
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 Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.
Arrow International is recalling 930 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life instead of 24 months.
Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.
Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.