Events

Rappel de Device Recall CADD1 5100 AMBULATORY INFUSION PUMP

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smiths Medical MD, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50829
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0987-2009
  • Date de mise en oeuvre de l'événement
    2008-12-09
  • Date de publication de l'événement
    2009-04-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77443
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FPA
  • Cause
    Smiths medical noticed an increased trend in leakage associated with 100 ml cadd medication cassette reservoirs reorder number 21-7002-24 lot numbers 213x18 and 214x18. if a leak occurs in a cadd medication cassette reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the reservoir. smiths medical has not received any report of patient injuries due.
  • Action
    An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to info.md@smiths-medical.com (in US) or international.customer.service@smiths-medical.com (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.

Device

Device Recall CADD1 5100 AMBULATORY INFUSION PUMP
  • Modèle / numéro de série
    Lot Numbers 213X18 and 214X18.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.
  • Description du dispositif
    CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. || CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Adresse du fabricant
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA