FDA (Devices) recall action 82070
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
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 45 units of Two-Lumen Central Venous Catheterization Sets due to incorrect priming volume labeling on the lidstock.
Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.