BEUDAMED
    FDA Enforcement Class II Terminated

    Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set

    Recall: Z-2179-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2179-2012
    Event ID
    62747
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Specialties Distributors, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    August 3, 2012
    Classification Date
    August 9, 2012
    Termination Date
    January 23, 2015
    Address
    800 Technology Center Dr, Stoughton, MA, 02072-4708, United States

    Description

    Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set

    Reason

    Devices leaking at the Y-site

    Code Info

    LOT NUMBER: 20111115

    Distribution

    Nationwide Distribution

    Quantity

    472 cases (50/case)