Events

Retiro De Equipo (Recall) de Device Recall Converters(R) Under Buttocks Drape with Fluid Control Pouch II,

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 Cardinal Health 200, LLC.

¿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
    77686
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2757-2017
  • Fecha de inicio del evento
    2017-06-27
  • Fecha de publicación del evento
    2017-07-07
  • 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=157504
  • 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
    Drape, surgical - Product Code KKX
  • Causa
    Outer label of some units of product number/lot number 8482, lot 16lfs235 and product number/lot number 9414, lot 16lus317 do not match the drape packaged inside.
  • Acción
    Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken: 1. Inspect your inventory for the affected product code and lot number (listed on the package) 2. segregate and quarantine all on-hand product 3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded. 4. Notify any customers to whom may have distributed or forwarded product affected by this product. 5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributor - 600-635-6021 All other customers - 888-444-5401 For questions regarding this recall call 800-327-7503.

Device

Device Recall Converters(R) Under Buttocks Drape with Fluid Control Pouch II,
  • Modelo / Serial
    Lot 16LFS235, expires November 1, 2021
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide including PR) and Canada
  • Descripción del producto
    Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL || A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • Dirección del fabricante
    Cardinal Health 200, LLC, 1500 S Waukegan Rd, Waukegan IL 60085-6728
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA