Events

Retiro De Equipo (Recall) de Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ethicon, 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
    79541
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1338-2018
  • Fecha de inicio del evento
    2018-01-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162607
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Causa
    Three (3) lots were distributed with the incorrect expiry date on the label. the lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
  • Acción
    On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2018. For further assistance contact 1-855-215-5039.

Device

Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures
  • Modelo / Serial
    Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distribution US Nationwide, Canada, India, and Colombia.
  • Descripción del producto
    PDS Plus Antibacterial (Polydioxanone) Suture || Size 0 PDS Plus Violet 36 || Single Armed CT-1 Needle
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Dirección del fabricante
    Ethicon, Inc., Us Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA