Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation
FDA device recall Z-1844-2015 · posted 2015-06-25 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- 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
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- OBJ
- Quantity affected
- 162 total devices (included both products)
- Distribution
- US Nationwide Distribution and one account in Canada.
- Date initiated
- 2015-06-04
- Date posted
- 2015-06-25
- Date terminated
- 2015-10-27
- Location
- Rancho Cordova, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISIONS PV .035 DITITAL IVUS CATHETER (K121273) | Volcano Corporation | 2012-09-10 |