FDA (Devices) recall action 82068
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 sterile barrier may contain packaging seal defects.
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.
Boston Scientific is recalling 18 units of Flexima Duodenal Bend Biliary Stents due to potential sterile barrier packaging seal defects.
Boston Scientific is recalling 75 units of Flexima Duodenal Bend Biliary Stents due to potential sterile barrier packaging seal defects.