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.
Recall
- Recall Number
- Z-1844-2015
- Event Number
- 71537
- Firm
- Volcano Corporation
- FEI Number
- 2939520
- Product Code
- OBJ
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- June 4, 2015
- Posted
- June 25, 2015
- Terminated
- October 27, 2015
- Address
- 2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133
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.
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
Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory.
US Nationwide Distribution and one account in Canada.
162 total devices (included both products)