IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for pall
FDA device recall Z-1550-2013 · posted 2013-06-18 · Terminated
Recall details
- Recalling firm
- IDEV Technologies, Inc.
- Reason for recall
- There was an error on the outer labeling of this device. The inner label was correct.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 3
- Distribution
- Nationwide Distribution to the states of FL, NY, and PA.
- Date initiated
- 2012-05-29
- Date posted
- 2013-06-18
- Date terminated
- 2013-07-29
- Location
- Webster, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS (K111766) | Idev Technologies, Inc. | 2011-10-19 |