DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- January 22, 2018
- Terminated
- September 24, 2019
- Recall Number
- Z-1291-2018
- Quantity
- 270
- Firm Location
- Center Valley, PA
Reason for Recall
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Distribution
US and Canada distribution
Lot / Code Info
DS Clip Appliers - Product Numbers PL808R DS SINGLE FIRE LAP.APPLIER L 12/310MM PL802R DS SINGLE FIRE LAP.APPLIER SM 5/310MM PL826R DS SINGLE FIRE LAP.APPLIER M 10/420MM PL817R DS SINGLE FIRE LAP.REM.FORC.ML 10/310MM PL828R DS SINGLE FIRE LAP.APPLIER L 12/420MM PL809R DS SINGLE FIRE LAP.APPLIER XL 12/310MM PL806R DS SINGLE FIRE LAP.APPLIER M 10/310MM PL818R DS SINGLE FIRE LAP.REM.FORC.L 12/310MM PL801R DS SINGLE FIRE LAP.APPLIER S 5/310MM PL816R DS SINGLE FIRE LAP.REM.FORC.M 10/310MM PL807R DS SINGLE FIRE LAP.APPLIER ML 10/310MM PL822R DS SINGLE FIRE LAP.APPLIER SM 5/420MM PL827R DS SINGLE FIRE LAP.APPLIER ML 10/420MM
Root Cause
Labeling design
Action Taken
A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned. IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use.