Device product
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.
Z-1845-2015
Product summary
- Event
- Event 71537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 162 total (both devices)
- Official record key
device-enforcement:Z-1845-2015
Official wording
Reason: 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
Code information: Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
Distribution pattern: US Nationwide Distribution and one account in Canada.
Derived failure modes
-
Unknown
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