Events

Recall of Device Recall Standard Drip Administration Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical Asd 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
    47474
  • Event Risk Class
    Class 3
  • Event Number
    Z-1549-2008
  • Event Initiated Date
    2008-03-24
  • Event Date Posted
    2008-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69548
  • 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
    IV Sets - Product Code LHI
  • Reason
    Misbranded/mispackaged device was distributed. product labeled to contain 72 inch standard drip ( iv) administration sets, actually contained 60 inch (iv) administration sets with a' y' site.
  • Action
    On 3/24/2008, the firm issued separate URGENT: PRODUCT RECALL NOTIFICATIONs sent via certified mail to their distributor and medical customers. Both recall notifications inform the customers of this labeling error and ask that the customers: 1) check their inventories for the presence of the suspect product; 2) complete and return the attached 'Product Recall Notification Response Form'; and 3) make arrangements to return any unused affected product to the recalling firm in exchange for a credit or replacement product. In addition, the distributors are asked to either provide the recalling firm with a list of their sub-account customers so that Smith Medical can contact the enduser customers and notify them of the recall, or as an alternative measure, the distributor can notify their branches and customers directly, via their own certified letter.

Device

Device Recall Standard Drip Administration Set
  • Model / Serial
    Lot #1217947.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.
  • Product Description
    Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. || Used to administer fluids.
  • Manufacturer
    Smiths Medical Asd Inc

Manufacturer

Smiths Medical Asd Inc
  • Manufacturer Address
    Smiths Medical Asd Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA