FDA (Devices) recall action 87218
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.
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
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.
DeRoyal Industries is recalling Heart Packs containing non-sterile sternum saw blades. The affected surgical saw blades are marked with a green non-sterile sticker.
DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.
DeRoyal Industries is recalling 1,084 Open Heart Packs because the included sternum saw blades were not sterile, despite being part of a surgical procedure pack.