Events

Retiro De Equipo (Recall) de Boston Sceintific CAPIO™ Polypropylene Blue Monofilament Nonabsorbable Surgical Sutures

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Teleflex Medical 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
    16399
  • Fecha de inicio del evento
    2014-03-21
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    Manufacturer has notified that certain lots of their products did not meet minimum needle attachment strength, knot tensile strength, minimum diameter, or minimum resorption strength requirements. this may result in suture breakage, delay in procedure, wound dehiscence, or the need for additional surgical intervention.
  • Acción
    Product to be returned to supplier

Device

Boston Sceintific CAPIO™ Polypropylene Blue Monofilament Nonabsorbable Surgical Sutures
  • Modelo / Serial
    Model: 833-124, Affected: 02A1200503, 02B1101450 02C0903400, 02D0900010 02D0900103, 02D1003285 02D1003286, 02F1302321 02G1000045, 02G1300348 02G1301122, 02H1100494 02L0803407, 02L1100009 02M1002289, 02M1101933
  • Manufacturer
    Teleflex Medical Inc

Manufacturer

Teleflex Medical Inc