Events

Retiro De Equipo (Recall) de Device Recall remel A.C.T. 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 Remel, 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
    54281
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1139-2010
  • Fecha de inicio del evento
    2010-01-18
  • Fecha de publicación del evento
    2010-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88132
  • 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
    culture media, non-propagating transport - Product Code JSM
  • Causa
    Pouch may be inadequately heat sealed compromising sterility.
  • Acción
    An IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" dated January 18, 2010, was sent to customers via regular mail. The notice described the product, problem, and action to be taken by the customers. The customers are requested to: review their inventory for the indicated product, discard all remaining units of the product lot, complete the "Product Inventory Checklist" enclosed to report the amount of product they wanted replaced or credited, and return by February 1, 2010 regardless if they have affected product and/or have verbally contacted the firm. If you have any inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 (USA) or 913-888-0930 (International).

Device

Device Recall remel A.C.T. II
  • Modelo / Serial
    Lot 834019, Exp 2010.10.27
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN
  • Descripción del producto
    remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. || Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.
  • Manufacturer
    Remel, Inc

Manufacturer

Remel, Inc
  • Dirección del fabricante
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA