Events

Rappel de TRANSVERSE LAPAROTOMY PACKS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARDINAL HEALTH CANADA 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
    52123
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-03-06
  • 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
    Cardinal health presource kits were exposed to temperature variations during transportation which are outside the range of the supplier's approved labelling. as such these temperature excursions may have impacted the effectiveness of certain components within the kits.

Device

TRANSVERSE LAPAROTOMY PACKS
  • Modèle / numéro de série
    Model Catalog: SBA30TRNHJ (Lot serial: 467489); Model Catalog: SAN30CLSLR (Lot serial: 468870); Model Catalog: SBA30MNNLE (Lot serial: 469042); Model Catalog: SAN30CCSLH (Lot serial: 468563); Model Catalog: SLC30LCNLF (Lot serial: 468653); Model Catalog: SAN30CLCRE (Lot serial: 468870); Model Catalog: SAN30CCUA1 (Lot serial: 468870); Model Catalog: SAN30CCSLH (Lot serial: 468870); Model Catalog: SAN30CLSLR (Lot serial: 469135); Model Catalog: SAN30CLCRE (Lot serial: 469135); Model Catalog: SAN30CCUA1 (Lot serial: 469135); Model Catalog: SAN30CCSLH (Lot serial: 469135); Model Catalog: SAN30CLSLR (Lot serial: 468238); Model Catalog: SAN30CLCRE (Lot serial: 468238); Model Catalog: SAN30CCUA1 (Lot serial: 468238); Model Catalog: SAN30CCSLH (Lot serial: 468238); Model Catalog: SAN30CLSLR (Lot serial: 468563); Model Catalog: SAN30CLCRE (Lot serial: 468563); Model Catalog: SAN30CCUA1 (Lot serial: 468563); Model Catalog: SCV30EPUA1 (Lot serial: 467711); Model Catalog: SBA30LTNLE (Lot serial: 468401); Model Catalog:
  • Description du dispositif
    TRANSVERSE LAPAROTOMY PACKS;CARDIAC CATHETERIZATION PACKS;MINOR LAPAROTOMY PACKS;LAP CHOLE PACKS;EP PACK;MINOR LITHOTONY PACKS;MAXIMAL BARRIER;ENSEMBLE PACEMAKER;KNEE PACKS;C SECTION PACK;CATHETERIZATION PACK;MAJOR LAPAROTOMY PACKS;ENSEMBLE CORONARY
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    HC