Events

Rappel de OPEN HEART PACK

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
    25828
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-04-30
  • 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
    These packs contain a light handle cover manufactured by medtronic (formerly covidien). the covidien devont light handle cover is a sterile plastic sheath that slides over the handle of the overhead surgical light. it allows a gloved surgeon or or nurse to grab the handle with sterile gloves to maintain sterility. medtronic has initiated a voluntary recall of the light handle cover due to potential defects that may compromise the integrity of the product. a copy of medtronic's recall letter is attached.

Device

OPEN HEART PACK
  • Modèle / numéro de série
    Model Catalog: DYNJ33026X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41666X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ33288X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ47601X (Lot serial: 14JB6768); Model Catalog: DYNJ46799X (Lot serial: 15MB6363); Model Catalog: DYNJ47601X (Lot serial: 14GB4580); Model Catalog: DYNJ46813X (Lot serial: 15CB7129); Model Catalog: DYNJ46813X (Lot serial: 14LB10457); Model Catalog: DYNJ46796X (Lot serial: 15BB7629); Model Catalog: DYNJ46801X (Lot serial: 15OB3443); Model Catalog: DYNJ46801X (Lot serial: 15NB1069); Model Catalog: DYNJ46801X (Lot serial: 14LB1053); Model Catalog: DYNJ40049X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41834X (Lot serial: 13TB1836); Model Catalog: DYNJ47601X (Lot serial: 14HB8722); Model Catalog: DYNJ41679X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41668X (Lot serial: 13IB1520); Model Catalog: DYNJ41668X (Lot serial: 13JB2275); Model Catalog: DYNJ41668X (Lot serial: 14MB0571
  • Description du dispositif
    Open Heart Pack
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION