FDA (Devices) recall action 95186
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
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 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier may compromise device sterility.
Boston Scientific is recalling the vanSonnenberg Sump Catheter System Kit because the sterile barrier pouch may have holes that could compromise device sterility. The recall affects 4 units distributed in the US, Colombia, Philippines, and Russia.
Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.
Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier pouch that may compromise device sterility.
Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.