FDA (Devices) recall action 64747
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.
Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
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.
Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.
Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.