Events

Recall of Device Recall CADDLegacy 1 Model 6400 Ambulatory Infusion Pump

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
    54284
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-2010
  • Event Initiated Date
    2009-12-23
  • Event Date Posted
    2010-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88142
  • 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
    Infusion Pump - Product Code FRN
  • Reason
    The cadd-legacy¿ 1 model 6400 ambulatory infusion pump (serial number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. if the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.
  • Action
    Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy¿ 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump.

Device

Device Recall CADDLegacy 1 Model 6400 Ambulatory Infusion Pump
  • Model / Serial
    Serial number: 370969
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MI
  • Product Description
    CADD-LEGACY¿ 1 Model 6400, Ambulatory Infusion Pump, || REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA