BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099

    Recall: Z-0756-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0756-2017
    Event ID
    75481
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    October 14, 2016
    Classification Date
    December 14, 2016
    Termination Date
    August 8, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099

    Reason

    Sterility of the outer surface of the container compromised due to packaging defect.

    Code Info

    All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X

    Distribution

    Nationwide Foreign: Japan

    Quantity

    5,187,100 Units