LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
This recall has been terminated (originally issued October 1, 2018).
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- October 1, 2018
- Terminated
- April 10, 2020
- Recall Number
- Z-0473-2019
- Quantity
- 46 units
- Firm Location
- Burlington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Pouches from this lot are not sealed compromising the sterility
Distribution
FL Foreign: Austalia, Korea
Lot / Code Info
LOT# PFP1055 Expiration Date: 2020-03-28
Root Cause
Packaging process control
Action Taken
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,