Events

Retiro De Equipo (Recall) de Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages

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 Dynarex 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
    29031
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0951-04
  • Fecha de inicio del evento
    2004-05-10
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33001
  • 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
    Bandage, Elastic - Product Code FQM
  • Causa
    Bandages labeled as "100% latex free" may contain latex. the wrapper was analytically tested by a private laboratory and found to contain latex.
  • Acción
    Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.

Device

Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages
  • Modelo / Serial
    Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Medical supply distributors located in NY, NJ, PA, TX, MN, GA, FL, MI, OH, IL, MS, KY, AZ , CA, NV, CO, and Puerto Rico, for further distribution to their customers. --- UPDATE: There were 2 foreign accounts in Panama that received the additional lots. The additional lots were distributed to the aforementioned states plus the following states: MA, MO, ME, VA, NC, LA.
  • Descripción del producto
    100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- || Device Listing # E177598. 510(k) Exempt.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Dirección del fabricante
    Dynarex Corporation, 10 Glenshaw Street, Orangeburg NY 10962-1207
  • Source
    USFDA