Events

Retiro De Equipo (Recall) de Device Recall LifeStyles Assorted Colors with Spermicide

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 Ansell Healthcare 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
    25095
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0402-03
  • Fecha de inicio del evento
    2002-11-25
  • Fecha de publicación del evento
    2002-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25148
  • 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
    Condom With Nonoxynol-9 - Product Code LTZ
  • Causa
    The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards.
  • Acción
    Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.

Device

Device Recall LifeStyles Assorted Colors with Spermicide
  • Modelo / Serial
    ANSELL HEALTHCARE INC.    LOT NUMBER PRODUCT CODE DESCRIPTION  0912C01622 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01522 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01422 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01322 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01222 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01122 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00322 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00222 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00122 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02222 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02122 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02022 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01922 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01822 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01722 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01622 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01522 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01422 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C02722 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C02522 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00722 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00622 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00522 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00422 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00322 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04122 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04022 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03922 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03022 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02922 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02222 6000 LS ASST CLRS W/SPL STPS 1000''S  0001990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0001991622 6000 LS ASST CLRS W/SPL STPS 1000''S 0001991922 6000 LS ASST CLRS W/SPL STPS 1000''S 0001992122 6000 LS ASST CLRS W/SPL STPS 1000''S 0002990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0002990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990622 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990722 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990622 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990722 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0005991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0006991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991122 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991322 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991422 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991522 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991622 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991722 6000 LS ASST CLRS W/SPL STPS 1000''S 0008990622 6003 LS ASST COLORS W/SPL FP 3''S 0008990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991122 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0008992022 6000 LS ASST CLRS W/SPL STPS 1000''S 0009991322 6003 LS ASST COLORS W/SPL FP 3''S 0009992122 6003 LS ASST COLORS W/SPL FP 3''S 0009992222 6003 LS ASST COLORS W/SPL FP 3''S 0106992622 6000 LS ASST CLRS W/SPL STPS 1000''S 0106992722 6000 LS ASST CLRS W/SPL STPS 1000''S
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Europe
  • Descripción del producto
    LifeStyles Assorted Colors Condoms with Spermicide
  • Manufacturer
    Ansell Healthcare Inc

Manufacturer

Ansell Healthcare Inc
  • Dirección del fabricante
    Ansell Healthcare Inc, 1500 Industrial Road, Dothan AL 36303
  • Source
    USFDA