Recall Z-1845-2015 ยท DQX Wire, Guide, Catheter
Volcano Corporation
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.
| Date | Jun 25, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| 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 |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 162 total (both devices) |
| Distribution | US Nationwide Distribution and one account in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111395 | PRIMEWIRE PRESTIGE PLUS Volcano Corporation, Aug 1, 2011 |