Events

Alerte Ou Avis De Sécurité sur Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Smiths Medical CADD.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2018-06-20
  • Date de publication de l'événement
    2018-06-20
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Adresse du fabricant
    Smiths Medical Tel: 01233 722 227Email: fieldactions@smiths-medical.comStericycleEmail: smithscadd101@stericycle.com
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    MHRA