FDA (Devices) recall action 85605
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 Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
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.
Cook Inc. is recalling 1,899 Pressure Monitoring Trays because excess coating material on the needle component could cause occlusion.
Cook Inc. is recalling 6,792 Pressure Monitoring Sets because excess coating material on the needle component could cause occlusion.