Events

Retiro De Equipo (Recall) de PTFE Coated 3 cm Flexible Tip Guidewire

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 Gyrus Acmi, Incorporated.

¿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
    58650
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2383-2011
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2011-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99779
  • 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
    Accessories, catheter, g-u - Product Code KNY
  • Causa
    Gyrus acmi, inc. wants to bring a recall issue to their customers attention concerning one lot of their 25bx-ptfe coated 3 cm flexible tip guidewire. as a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. in such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected,.
  • Acción
    The firm, Olympus ACMI, sent an "Urgent: Medical Device Recall" letter dated April 15, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Inspect their stock to confirm if any of the affected lot of products remains in their possession 2)Immediately cease any further use of the affected product, remove, quarantine and return it. 3) Call their Gyrus ACMI customer service representative at 1-888-542-7266 to obtain a Returned Goods Authorization 4) Return the product to: Attn: PTFE Guidewire Recall RGA#_________Gyrus ACMI LP, 6845 Wedgwood Court, Maple Grove, MN 55311 5) Complete and return the RECALL REPLY FORM via fax, even if they are returning no product, to: Regulator Affairs (508) 804-2624. The letter states that the customer will receive repeat mailings until they have faxed in the form. Additionally, If they have further distributed the product they are requested to identify and notify their customers at once. If you have any questions, please do not hesitate to contact customer service at 1-888-524-7266.

Device

PTFE Coated 3 cm Flexible Tip Guidewire
  • Modelo / Serial
    Lot Number 252410KC
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, GA, HI, IN, KY, MT, NY, NC, PA, TX, UT, and WA.
  • Descripción del producto
    Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA || Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Dirección del fabricante
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA