Device product
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Z-1844-2015
Product summary
- Event
- Event 71537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 162 total devices (included both products)
- Official record key
device-enforcement:Z-1844-2015
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 88901; lot number 50002518
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