Z-1550-2013 Class II Terminated

Recalled by IDEV Technologies, Inc. — Webster, TX

Recall Details

Product Type
Devices
Report Date
June 26, 2013
Initiation Date
May 29, 2012
Termination Date
July 29, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

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.

Distribution Pattern

Nationwide Distribution to the states of FL, NY, and PA.

Code Information

Model Number: S-05-100-120-G3; Lot Number 01049037