FDA (Devices) recall action 84212
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
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 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
Cook Inc. is recalling 58 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.