Recall Z-2448-2019 ยท MJN Catheter, Intravascular Occluding, Temporary
LeMaitre Vascular, Inc.
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflatio
| Date | Jul 24, 2019 |
| Status | Terminated |
| Reason | incorrect device size being listed on the impacted device packaging |
| Root cause | Labeling mix-ups |
| Action | 1. Quarantine any catalog # 2107-80 devices from lot OLC1051. 2. Complete the enclosed customer reply form and return it to LeMaitre Vascular GmbH by scanning it and emailing it to recalls-emea@lemaitre.com. NOTE: The customer reply form must be returned even if you have no devices at your facility. 3. LeMaitre Vascular GmbH will contact you with information on how to return the product and they will send you replacement devices. For further information about this recall, contact Tobias Malcharczik at tmalcharczik@lemaitre.com. |
| Quantity | 62 units |
| Distribution | GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132022 | LEMAITRE 8F OCCLUSION CATHETER LeMaitre Vascular, Inc., Nov 6, 2013 |