Z-1844-2015 Class II Terminated
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 devices (included both products)
Product Description
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.
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 88901; lot number 50002518