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Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip, used in laparoscopic surgery
Recalled April 11, 2018 · FDA recall Z-1290-2018 · Aesculap Implant Systems
Hazard
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. · FDA Class II
Units
9621
Sold at
US and Canada distribution
Description
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.
Product
DS Titanium Ligation Clip, used in laparoscopic surgery
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →