Events

Rappel de JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS

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
    52558
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-27
  • 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 has become aware of a potential breach of sterility in the packaging of certain jackson-pratt perforated and hemaduct wound drainage systems. in a small percentage of product (approximately 1.6%) the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch potentially compromising the sterility of the package contents. while sterility is only impacted if the polybag fully breaches the seal (approximately 0.23% of product) as a precautionary measure cardinal health is taking this action to ensure that product is not used if any portion of the polybag is caught in the seal area. use of impacted products could result in an increased risk of infection.

Device

JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS
  • Modèle / numéro de série
    Model Catalog: SU130-1309 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1308 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUF100 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1310 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1410 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1411 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1311 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1323 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1321 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1320 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0323 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0321 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0521 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR190 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR151 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR
  • Description du dispositif
    JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS;JACKSON-PRATT SILICONE ROUND DRAINS W/WO TROCARS;JACKSON-PRATT PVC ROUND DRAINS WITH ATTACHED TROCAR
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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