The Australia Therapeutic Goods Administration (TGA) has issued a medical device safety alert concerning LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier manufactured by Ethicon Endo-Surgery, LLC (a Johnson & Johnson company). The affected code number is ER320 (with expiration dates from November 2016 to March 2018).
The manufacturer has identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure. Product recall of affected units is on-going.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00396-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 7 May 2013