Recall Z-1507-2012 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Cat
| Date | May 10, 2012 (initiated Apr 9, 2012) |
| Status | Terminated |
| Reason | Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in the Tyvek packaging. |
| Root cause | Packaging process control |
| Action | Cordis Corp sent a " Urgent Medical Device Recall (Removal) letter dated April 9, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A Response Form was provided with each notification. Customers were asked to complete and return Response Form. The customers were instructed to : " Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. " Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on |
| Quantity | 984 uits |
| Distribution | Worldwide Distribution-- USA (nationwide) and the country Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031777 | MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp., Jul 7, 2003 |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp., Nov 8, 2004 |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB Cordis Corp., Feb 6, 2008 |