BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0473-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0473-2019
    Event ID
    81391
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2018
    Initiation Date
    October 1, 2018
    Classification Date
    November 16, 2018
    Termination Date
    April 10, 2020
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    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

    Code Info

    LOT# PFP1055 Expiration Date: 2020-03-28

    Distribution

    FL Foreign: Austalia, Korea

    Quantity

    46 units