Events

Rappel de Device Recall Smiths Medical HOTLINE 3 Blood and Fluid Warmer

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 ASD, 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
    62389
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1979-2012
  • Date de mise en oeuvre de l'événement
    2012-06-27
  • Date de publication de l'événement
    2012-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110397
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • Cause
    Hotline 3 blood and fluid warmer( reorder no. hl-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable.
  • Action
    Smiths Medical sent an Urgent Medical Device Correction -Field Safety Notice letter dated June 21, 2012 via U.S. Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter included an Urgent Medical Device Field Safety Notice Acknowledgement Form ("Confirmation Form") that customers were instructed to complete and return to Smiths Medical for carrying out the correction and affectivity tracking purposes. The letter stated that a Smiths Medical Representative will visit the affected sites to correct the units with a shelf upgrade kit, which includes instructions and all the parts necessary to make the correction to their affected devices. Customers were provided with a form to record the serial numbers of the devices corrected so that this can be returned to Smiths Medical. For questions regarding this information call Smiths Medical Quality Department at 1-781-763-9335. .

Device

Device Recall Smiths Medical HOTLINE 3 Blood and Fluid Warmer
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, || Reorder Numbers: HL-390 || Product Usage: || The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA