FDA (Devices) recall action 83324
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
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.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.