Events

Recall of Medstream 81" (206cm) 20 Universal Administration Set with YSite

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Specialties Distributors, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62747
  • Event Risk Class
    Class 2
  • Event Number
    Z-2179-2012
  • Event Initiated Date
    2012-08-03
  • Event Date Posted
    2012-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111584
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • 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.

Device

Medstream 81" (206cm) 20 Universal Administration Set with YSite
  • Model / Serial
    LOT NUMBER: 20111115
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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
  • Manufacturer
    Medical Specialties Distributors, Inc.

Manufacturer

Medical Specialties Distributors, Inc.
  • Manufacturer Address
    Medical Specialties Distributors, Inc., 800 Technology Center Dr, Stoughton MA 02072-4708
  • Manufacturer Parent Company (2017)
    Medical Specialties Distributors Inc.
  • Source
    USFDA