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U.S. Department of Health and Human Services

Class 2 Device Recall SUPERA VERITAS

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 Class 2 Recall
SUPERA VERITAS
see related information
Date Posted June 18, 2013
Recall Status1 Terminated on July 29, 2013
Recall Number Z-1550-2013
Recall Event ID 65245
Premarket Notification
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, Texas 77598-4213
Manufacturer Reason
for Recall
There was an error on the outer labeling of this device. The inner label was correct.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = IDEV TECHNOLOGIES, INC.
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