Events

Recall of Device Recall AddOn Kids Kit

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
    45889
  • Event Risk Class
    Class 3
  • Event Number
    Z-0696-2008
  • Event Initiated Date
    2007-11-21
  • Event Date Posted
    2008-01-31
  • 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=66416
  • 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
    Blood Sampling System, - Product Code CBT
  • Reason
    Misbranded; the product codes are labeled incorrectly with a green promotional label for "new split septum sampling site. only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, not with a needle-free access device.
  • Action
    Smiths Medical mailed certified letters (Urgent Product Advisory Notifications) dated November 19, 2007, to all customers that received the affected lot. Firms are instructed to make the field correction (extra label removal) or mail the product back to Smiths for the correction.

Device

Device Recall AddOn Kids Kit
  • Model / Serial
    Lot Numbers: 1189082, 1231444, 1178100, and 1225588.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.
  • Product Description
    Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016
  • 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