Recall Z-0909-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled.
| Date | Jul 20, 2004 (initiated Jan 13, 2004) |
| Status | Terminated |
| Reason | Air may be introduced into this Stent system when used with certain size acessory devices. |
| Root cause | Other |
| Action | On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling. |
| Quantity | 7815 |
| Distribution | Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032137 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp., Sep 17, 2003 |