Recall Z-2636-2014 ยท DQO Catheter, Intravascular, Diagnostic
Volcano Corporation
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
| Date | Sep 12, 2014 (initiated Aug 13, 2014) |
| Status | Terminated |
| Reason | Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. |
| Root cause | Packaging |
| Action | Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for a |
| Quantity | 8251 total devices (3777 US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003938 | TRAK BACK II Jomed, Inc., Jan 18, 2001 |