FDAClass IIApril 11, 2018

DS Titanium Ligation Clip Appliers recall

DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

Why was DS Titanium Ligation Clip Appliers recalled?

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Recalling firm
Aesculap Implant Systems LLC
Quantity
270
Distribution
US and Canada distribution
Recall date
April 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls