Events

Retiro De Equipo (Recall) de Device Recall LifeShield Primary I.V. Plumset

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 Hospira 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
    54079
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1349-2010
  • Fecha de inicio del evento
    2009-11-24
  • Fecha de publicación del evento
    2010-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87668
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Intravascular Administration Set - Product Code FPA
  • Causa
    Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
  • Acción
    Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.

Device

Device Recall LifeShield Primary I.V. Plumset
  • Modelo / Serial
    Lot numbers: 551765H, 561175H, 580355H, 591025H, 601015H, 610425H, and 620585H.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Descripción del producto
    Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 103 inch with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 19306-12.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 375 N Field Dr, Lake Forest IL 60045-2513
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA