Events

Rappel de TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ICU MEDICAL 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
    149406
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-09-30
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Icu medical inc. has identified a potential leak with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or potentially introduce a small amounts of air into the line.

Device

TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH
  • Modèle / numéro de série
    Model Catalog: 42587-05 (Lot serial: 3247898); Model Catalog: 42590-05 (Lot serial: 3247898); Model Catalog: 42587-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3292882); Model Catalog: 42587-05 (Lot serial: 3292882); Model Catalog: 011-46104-41 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42583-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42584-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42585-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 011-46101-92 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42582-06 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3257008); Model Catalog: 42582-06 (Lot serial: 3257008); Model Catalog: 46107-53 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3264105); Model Catalog: 42594-05 (Lot serial: 3265442); Model Catalog: 42582-06 (Lot serial: 3264105); Model Catalog: 42641-06 (Lot serial: 3249806)
  • Description du dispositif
    TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH;TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH 3 ML SQUEEZE FLUSH DEVICE;TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS;TRANSPAC IV MONITORING KIT W/4 WAY STOPCOCK 3 WAY STOPCOCK AND
  • Manufacturer
    ICU MEDICAL INC.

Manufacturer

ICU MEDICAL INC.
  • Adresse du fabricant
    SAN CLEMENTE
  • Société-mère du fabricant (2017)
    ICU Medical, Inc.
  • Source
    HC