Events

Recall of CADDSolis Medication Safety Software

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
    69408
  • Event Risk Class
    Class 2
  • Event Number
    Z-0166-2015
  • Event Date Posted
    2014-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130449
  • 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
    Pump, infusion, pca - Product Code MEA
  • Reason
    Smiths medical has identified an issue with a single batch (lot number 2752712) of cadd"-solis medication safety software administrator 3.1 cds. cadd"-solis medication safety software administrator 3.1 cds were sent with the cadd"-solis medication safety software point of care 3.1 software loaded on them.
  • Action
    Consignees were hand delivered by Smiths Medical Sales representatives on 9/29/2014 a Smiths Medical "Urgent Field Safety Notice" dated 25-September-14. The letter described the problem and the product being recalled. The letter also provided the Advice on Action to be Taken by the User, Transmission of this Urgent Medical Device Recall Notice and requested consignees to complete and return the Confirmation Form by fax to 1-800-237-8033 or via email to recall.response@smiths-medical.com. For questions customers can contact Smiths Medical's Customer Service Department at 1-800-258-5361.

Device

CADDSolis Medication Safety Software
  • Model / Serial
    Lot Number 2752712
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
  • Product Description
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. || Product Usage: || The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
  • 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