Date Initiated by Firm |
May 29, 2012 |
Date Posted |
June 18, 2013 |
Recall Status1 |
Terminated 3 on July 29, 2013 |
Recall Number |
Z-1550-2013 |
Recall Event ID |
65245 |
510(K)Number |
K111766
|
Product Classification |
Catheter, biliary, diagnostic - Product Code FGE
|
Product |
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms |
Code Information |
Model Number: S-05-100-120-G3; Lot Number 01049037 |
Recalling Firm/ Manufacturer |
IDEV Technologies, Inc. 253 Medical Center Blvd Webster TX 77598-4213
|
For Additional Information Contact |
281-525-2000
|
Manufacturer Reason for Recall |
There was an error on the outer labeling of this device. The inner label was correct.
|
FDA Determined Cause 2 |
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 in Commerce |
3 |
Distribution |
Nationwide Distribution to the states of FL, NY, and PA. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FGE and Original Applicant = IDEV TECHNOLOGIES, INC.
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