SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative t
FDA device recall Z-1213-2012 · posted 2012-03-15 · Terminated
Recall details
- Recalling firm
- Idev Technologies, Inc.
- Reason for recall
- The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- Seven devices
- Distribution
- Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.
- Date initiated
- 2012-01-31
- Date posted
- 2012-03-15
- Date terminated
- 2013-09-09
- 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 TRANSHEPATIC BILIARY SYSTEM (K093893) | Idev Technologies, Inc. | 2010-10-05 |