BEUDAMED
    FDA Recall Terminated

    LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

    Recall: Z-0473-2019 · Initiated October 1, 2018

    Recall

    Recall Number
    Z-0473-2019
    Event Number
    81391
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    MJN
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 1, 2018
    Terminated
    April 10, 2020
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

    Reason

    Pouches from this lot are not sealed compromising the sterility

    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: [email protected] 781-425-1671 Monday through Friday, 8:00 AM to 4:30 PM,

    Distribution

    FL Foreign: Austalia, Korea

    Quantity

    46 units