Events

Rappel de SYNTRA DIALYZER 120

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER 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
    21917
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2002-09-12
  • 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
    Manufacturer has received a small number of confirmed reports of saline and blood leaks from the header during priming of the dialyzer.

Device

SYNTRA DIALYZER 120
  • Modèle / numéro de série
    Model Catalog: R5M6243 (Lot serial: 4.); Model Catalog: R5M6246 (Lot serial: H02D26112 H02D21118 H02F2202); Model Catalog: R5M6243 (Lot serial: H02C20133 H02C20133A H02F110); Model Catalog: R5M6243 (Lot serial: 2C13112A H02C15083 H02C18152); Model Catalog: R5M6243 (Lot serial: 0102 H02B02018 H02C13112 H0); Model Catalog: R5M6243 (Lot serial: 5 H01L14048 H02A29138 H02A3); Model Catalog: R5M6243 (Lot serial: H01J13044 H01J15155 H01L1250); Model Catalog: R5M6243 (Lot serial: 3481 H01I27029 H01I29017A); Model Catalog: R5M6243 (Lot serial: H01G30068 H01H01075 H01H0203); Model Catalog: R5M6243 (Lot serial: 0040 H01E02129 H01G02067); Model Catalog: R5M6243 (Lot serial: 4 H01D09036 H01D10091 H01D3); Model Catalog: R5M6243 (Lot serial: h01c05093H01C26032 H01D0503); Model Catalog: R5M6243 (Lot serial: 2 H01H24077 H01H25025 H01I2); Model Catalog: R5M6243 (Lot serial: H02F17041 H02F18106 H02F1849); Model Catalog: R5M6246 (Lot serial: 02071 H02D07492 H02D22152); Model Catalog: R5M6246 (Lot serial: 64 H02C10506 H02C11561
  • Description du dispositif
    SYNTRA 120 DIALYZER
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION