BEUDAMED
    FDA Enforcement Class II Terminated

    Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

    Recall: Z-0273-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0273-2020
    Event ID
    83762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermo Fisher Scientific (Monterrey)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 13, 2019
    Initiation Date
    July 18, 2019
    Classification Date
    November 1, 2019
    Termination Date
    May 18, 2020
    Address
    Blvd Apodaca 500, Apodaca Technology Park, Apodaca Nuevo Leon 66600, N/A, N/A, Mexico

    Description

    Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

    Reason

    Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

    Code Info

    Lot # 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, 1252504

    Distribution

    OH

    Quantity

    514,200 each