Recall Z-1550-2013— IDEV Technologies, Inc.

Name: FDA recall Z-1550-2013
Creator: U.S. Food and Drug Administration
Published: 2012-05-29

Class II · Terminated

Class II FDA medical device recall by IDEV Technologies, Inc., initiated 2012-05-29, terminated 2013-07-29. It names one FDA 510(k) clearance: K111766. Product: IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms. Reason: There was an error on the outer labeling of this device. The inner label was correct..

Recalling firm: IDEV Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Terminated: 2013-07-29
Firm location: Webster, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K111766 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMSIdev Technologies, Inc.·cleared 2011-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms

Reason for recall

There was an error on the outer labeling of this device. The inner label was correct.

Data sourced from openFDA. This site is unofficial and independent of the FDA.