FDA (Devices) recall action 79530
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.
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.
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.
Aesculap Implant Systems LLC is recalling 270 DS Titanium Ligation Clip Appliers to update instructions for use, adding contraindications for living donor nephrectomies.
Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.