Events

Retiro De Equipo (Recall) de MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP EXTRA LONG

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

¿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
    64991
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-24
  • 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
    Baxter is sending an important safety update to the instructions for use for baxter peritoneal dialysis (pd) transfer sets titanium adapters disconnect caps and connection shield product codes. specifically baxter is adding contraindication statements to address iodine allergy for baxter's pd products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended. there is no product hold or physical removal of devices from the field associated with this action.

Device

MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP EXTRA LONG
  • Modelo / Serial
    Model Catalog: R5C4484 (Lot serial: H09K16070); Model Catalog: R5C4484 (Lot serial: H11F15077); Model Catalog: R5C4484 (Lot serial: H12F14061); Model Catalog: R5C4484 (Lot serial: H13E14047); Model Catalog: R5C4484 (Lot serial: H13J10020); Model Catalog: R5C4484 (Lot serial: H13L13046); Model Catalog: SPC4466 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: SPC4213 (Lot serial: 12D28H10); Model Catalog: SPC4213 (Lot serial: 12G24H10); Model Catalog: SPC4211 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: SPC4213 (Lot serial: 10B11H12); Model Catalog: SPC4213 (Lot serial: 11D01H10); Model Catalog: SPC4213 (Lot serial: 14G07H10); Model Catalog: SPC4486 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    MINICAP EXT LIFE PD TRANSTWISTXLONG
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION