Events

Retiro De Equipo (Recall) de PRESSURE INJECTABLE PICC KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TELEFLEX MEDICAL CANADA INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    84138
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-04-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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:
  • Descripción del producto
    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.