Events

Rappel de PRESSURE INJECTABLE PICC KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TELEFLEX MEDICAL 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
    84138
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-04-07
  • 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
    Arrow kits contain bd eclipse needles for which bd has received reports of safety cover disengagement and needlestick injury. in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible "click" sound before the safety cover is locked (activated) followed by a second "click" sound when the safety cover is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover is locked after the initial "click.".

Device

PRESSURE INJECTABLE PICC KIT
  • Modèle / numéro de série
    Model Catalog: EU-05041-HPMSB (Lot serial: ALL); Model Catalog: EU-05052-HPMSB (Lot serial: ALL); Model Catalog: EU-04052-HPMSB (Lot serial: ALL); Model Catalog: EU-04041-HPMSB (Lot serial: ALL); Model Catalog: CDA-47702-P1A (Lot serial: ALL); Model Catalog: CDA-45703-P1A (Lot serial: ALL); Model Catalog: CDA-42802-P1A (Lot serial: ALL); Model Catalog: CDA-42703-P1A (Lot serial: ALL); Model Catalog: CA-47702-P1A (Lot serial: ALL); Model Catalog: CA-45703-P1A (Lot serial: ALL); Model Catalog: CA-42703-P1A (Lot serial: ALL); Model Catalog: CDA-29803-1A (Lot serial: ALL); Model Catalog: CDA-25123-1A (Lot serial: ALL); Model Catalog: EU-05541-HPMSB (Lot serial: ALL); Model Catalog: ASK-22702-CA (Lot serial: ALL); Model Catalog: ASK-45703-PRJ (Lot serial: ALL); Model Catalog: ASK-42703-PRJ (Lot serial: ALL); Model Catalog: CDA-45052-HPK1A (Lot serial: ALL); Model Catalog: CDA-45854-P1A (Lot serial: ALL); Model Catalog: CDA-42854-P1A (Lot serial: ALL); Model Catalog: CA-45854-P1A (Lot serial: ALL); Model Catalog:
  • Description du dispositif
    PRESSURE INJECTABLE PICC KIT;AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT;PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE SHEATH INTEGRAL HEMOSTASIS VALVE/SIDE PORT AND MAXIMAL BARRIER PRECAUTIONS;ARROWG+ARD BLUE LARGE BORE MULTI-LUMEN CVC KIT FOR
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.