BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

    Recall: Z-2629-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2629-2014
    Event ID
    68585
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 24, 2014
    Initiation Date
    June 23, 2014
    Classification Date
    September 12, 2014
    Termination Date
    January 29, 2021
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    Description

    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

    Reason

    Products were held at improper storage temperature

    Code Info

    Lot::3319877

    Distribution

    Distributed in the states of LA, OK, and TX.

    Quantity

    3 boxes