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U.S. Department of Health and Human Services

Class 2 Device Recall Stent Delivery Catheter

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  Class 2 Device Recall Stent Delivery Catheter see related information
Date Initiated by Firm January 31, 2012
Date Posted March 15, 2012
Recall Status1 Terminated 3 on September 09, 2013
Recall Number Z-1213-2012
Recall Event ID 61090
510(K)Number K093893  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.

Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
Code Information Device Codes: S-04-120-120-G3 (Lot Number 05180062); S-04-040-120-G3 (Lot Numbers 05180031); S-04-060-120-G3 (Lot Number 05187032); S-05-040-120-G3 (Lot Number 05180034); S-05-060-120-G3 (Lot Number 05180035); S-05-080-120-G3 (Lot Number 05180036); S-05-100-120-G3 (Lot Number 05180037); and S-06-080-120-G3 (Lot Number 05180042).   
Recalling Firm/
Manufacturer		 Idev Technologies, Inc.
253 Medical Center Blvd
Webster TX 77598
For Additional Information Contact Darlene Garner
281-525-2052
Manufacturer 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).
FDA Determined
Cause 2		 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 in Commerce Seven devices
Distribution Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.
Total Product Life Cycle TPLC Device Report
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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