Recall Z-1213-2012 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Idev Technologies, Inc.
SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
| Date | Mar 15, 2012 (initiated Jan 31, 2012) |
| Status | Terminated |
| Reason | The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length). |
| Root cause | Labeling mix-ups |
| Action | IDEV Technologies sent an "URGENT PRODUCT RECALL" letter dated February 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to sign the letter and return a copy to the firm via fax to 281-525-2001 to indicate that they have received the notification. Contact the firm at 281-525-2052 for questions regarding the notice. |
| Quantity | Seven devices |
| Distribution | Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093893 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Idev Technologies, Inc., Oct 5, 2010 |