Z-1550-2013 Class II Terminated
FDA device recall Z-1550-2013 was initiated by IDEV Technologies, Inc. on May 29, 2012 and is designated Class II. Reason for recall: There was an error on the outer labeling of this device. The inner label was correct. The recall status is terminated (terminated July 29, 2013). Affected quantity: 3.
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