Z-1845-2015 Class II Terminated
FDA device recall Z-1845-2015 was initiated by Volcano Corporation on June 4, 2015 and is designated Class II. Reason for recall: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf lif… The recall status is terminated (terminated October 27, 2015). Affected quantity: 162 total (both devices).
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2015
- Initiation Date
- June 4, 2015
- Termination Date
- October 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162 total (both devices)
Product Description
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Reason for Recall
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Distribution Pattern
US Nationwide Distribution and one account in Canada.
Code Information
Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.