Recall Z-2808-2015 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
| Date | Sep 23, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure. |
| Root cause | Labeling False and Misleading |
| Action | Customer letter notification with reply form will be sent via Federal Express with delivery confirmation for US consignees on 7/20/15 informing them of the incorrect indication for use contained in the brochure. |
| Quantity | 1811 |
| Distribution | Distributed to domestic and foreign conference attendees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.