Recall Z-0473-2019 ยท MJN Catheter, Intravascular Occluding, Temporary
LeMaitre Vascular, Inc.
LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
| Date | Oct 1, 2018 |
| Status | Terminated |
| Reason | Pouches from this lot are not sealed compromising the sterility |
| Root cause | Packaging process control |
| Action | Lemaitre Vascular initiated recall by letter on October 1, 2018, provided with reason for recall action to be taken, risk to health. Complete the enclosed customer reply form, and return it to LeMaitre Vascular, Inc. Return all devices from lot PFP1055, whether they appear to be unsealed or not. If you distributed any affected product to other facilities, please forward this recall to the recipients. Contact Information: rlerer@lemaitre.com 781-425-1671 Monday through Friday, 8:00 AM to 4:30 PM, |
| Quantity | 46 units |
| Distribution | FL Foreign: Austalia, Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt LeMaitre Vascular, Inc., Jan 21, 2016 |