Recall Z-1550-2013 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
IDEV Technologies, Inc.
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
| Date | Jun 18, 2013 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | There was an error on the outer labeling of this device. The inner label was correct. |
| Root cause | Labeling mix-ups |
| Action | The firm decided to rework the products that were in their control at the time and the one that was not in their control was corrected by an IDEV employee. That hospital was called and notified of the situation in May 2012. |
| Quantity | 3 |
| Distribution | Nationwide Distribution to the states of FL, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS Idev Technologies, Inc., Oct 19, 2011 |