Events

Safety Alert Or Field Safety Notices for Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Smiths Medical CADD.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-06-20
  • Event Date Posted
    2018-06-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/smiths-medical-cadd-non-flow-stop-medication-cassette-reservoirs-recall-of-specific-lots-due-to-risk-of-under-delivery-of-medication
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Smiths medical cadd® non flow-stop medication cassette reservoirs may have been manufactured with an incorrect pressure plate which could cause partial or total occlusion of the tubing with no alarm.
  • Action
    Refer to the manufacturer’s Field Safety Notice (FSN) for a list of affected product codes and the attached spreadsheet for a list of affected lots Identify, stop using and quarantine these devices Contact Stericycle to return the devices as directed in the manufacturer’s FSN

Device

Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs
  • Model / Serial
  • Product Description
    CADD® Medication Cassette Reservoirs are intended for ambulatory volumetric infusion of small doses (up to 50ml,100ml, or 250ml), and are designed to be used with a variety of CADD ambulatory infusion pumps (except CADD-Micro™, CADD-MS® 3 and CADD-TPN® pumps).In addition to the Field Safety Notice which details affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information, and models and lot numbers.
  • Manufacturer
    Smiths Medical CADD

Manufacturer

Smiths Medical CADD
  • Manufacturer Address
    Smiths Medical Tel: 01233 722 227Email: fieldactions@smiths-medical.comStericycleEmail: smithscadd101@stericycle.com
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    MHRA