Events

Retiro De Equipo (Recall) de Device Recall 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket

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 3M Company - Health Care Business.

¿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
    79002
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0598-2018
  • Fecha de inicio del evento
    2018-01-23
  • 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=161064
  • 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
    System, thermal regulating - Product Code DWJ
  • Causa
    Adesign change to 3m(tm) bair hugger(tm) full access underbody warming blanket, models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
  • Acción
    The firm, 3M, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 1/19/2018 to its customers on 01/23/2018. The end user letter requested the following: "Actions Required: 1) Please immediately identify the affected product listed above, remove from your inventory and DO NOT USE. 2) Follow the instructions on the attached Customer Product Recall Acknowledgement Form, complete the form and return it to 3M via email at 3Mhealthcare@montage72.com. 3) Please dispose of all affected product per your institutional protocol and document disposal in the recall acknowledgment form." The distributor letter requested the following: "Actions Required: 1. Immediately discontinue distribution of the 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above. 2. Determine if any stock of the 3M" Bair Hugger" Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above remains in your inventory. 3. Complete the attached Distributor Product Recall Acknowledgement Form and return to 3M via email at 3Mhealthcare@montage72.com. It is important to notify 3M whether or not your facility has any inventory of this product. 4. Notify any of your customers who may have received the lots. Please use the attached customer notice and form provided in your communications to the customer. Customers should complete and return the enclosed form to 3M per the instructions on the form. Customers should not use the affected product and dispose per institutional protocol. 5. Dispose of any affected product in your inventory and document disposal in the recall acknowledgment form." If you have questions regarding this matter, please contact the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m.  6:00 p.m. Central Daylight Time.

Device

Device Recall 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket
  • Modelo / Serial
    Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.
  • Descripción del producto
    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 || The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Dirección del fabricante
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA