BEUDAMED
    FDA Recall 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 · Initiated August 3, 2012

    Recall

    Recall Number
    Z-2179-2012
    Event Number
    62747
    Firm
    Medical Specialties Distributors, Inc.
    FEI Number
    1221252
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 3, 2012
    Posted
    August 9, 2012
    Terminated
    January 23, 2015
    Address
    800 Technology Center Dr, Stoughton, MA, 02072-4708

    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

    Action

    Medical Specialties Distributors LLC sent an Urgent Medical Recall letter dated August 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and remove all affected product from use immediately. Further distribution of the affected product should be discontinued immediately. Customers were instructed to contact their customers and inform them of the recall; complete and return the acknowledgement form and fax to 781-344-8320 to arrange for a return and to contact the Customer Service Department at (800) 967-6400 with questions. For questions regarding this recall call 781-344-6000.

    Distribution

    Nationwide Distribution

    Quantity

    472 cases (50/case)