Recall Z-1453-2017 ยท DQO Catheter, Intravascular, Diagnostic
LeMaitre Vascular, Inc.
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
| Date | Feb 7, 2017 |
| Status | Terminated |
| Reason | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Root cause | Labeling design |
| Action | LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183. |
| Quantity | 46 |
| Distribution | Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.