Events

Rappel de SIRUS SURGICAL GOWN

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDLINE CANADA CORPORATION.

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
    144477
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-06-07
  • 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
    Medline industries was informed by the vendor that one lot of sirus surgical gown product code dynjp2229s was manufactured with inconsistent sealing of the breathable sleeve seam material. the gown is manufactured using a spunbond-meltblown-spunbond (sms} base material which is used for the body of the gown. the chest area/critical zone is reinforced with a polyethylene coated spunbond polypropylene material. the arms are manufactured using a breathable film material which is stitched to the body. the gown is labeled as an aami level 4 gown. the sleeve seam of the breathable material was found to have inconsistent sealing which has the potential to allow fluid to flow pass through the protective seam. this defect was detected during laboratory testing per astm f 1671 - standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using phi-x174 bacteriophage penetration where failures were seen at the sleeve seam. no complaints or mdr's have been filed for open seams or for fluid passing through the seams onto the user.

Device

SIRUS SURGICAL GOWN
  • Modèle / numéro de série
    Model Catalog: DYNJP2229S (Lot serial: 45016070513PH)
  • Description du dispositif
    SIRUS SURGICAL GOWN
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION