Recall Z-1844-2015
Volcano Corporation · initiated June 4, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product number 88901; lot number 50002518
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
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-1844-2015
- Initiated
- June 4, 2015
- Posted by FDA
- June 25, 2015
- Terminated
- October 27, 2015
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 162 total devices (included both products)
- Distribution
- US Nationwide Distribution and one account in Canada.
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1845-2015 Class II | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is…During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in… | 06/04/2015Terminated |