Retiro De Equipo (Recall) de BHM/MediMan Combi Sling

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 B.H.M. Medical, 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
    51999
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1990-2009
  • Fecha de inicio del evento
    2009-04-07
  • Fecha de publicación del evento
    2009-08-31
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Combi Sling - Product Code FNG
  • Causa
    Premature failure of the stitching at the junction of the shoulder strap and sling body of the bhm/medi-man combi sling used with patient lifts.
  • Acción
    Arjo sent "Urgent Device Recall Customer Notification" cover letters dated April 15, 2009 to the end user accounts who received the affected BHM/Medi-Man Combi Slings, to the attention of the Administrator/Risk Manager, advising them of the potential for possible stitching failure that could lead to a hazardous situation. Enclosed with the letter was a copy of the BHM Medical Field Safety Notice, FSN 10/2009/ca, dated April 3, 2009 which was sent to their BHM customers in the U.S. on April 7, 2009. The FSN identified the part numbers of the BHM/Medi-Man Combi Slings, described the potential health hazard, and listed the actions to take. The accounts were instructed to inspect and assess their slings' suitability for use per the Slings Maintenance Instructions. If the sling is showing this kind of breakage, the account was instructed to remove it from use and discard it immediately. If the inspection reveals no deterioration of the stitching, the sling is safe to use. The accounts were requested to complete and return the enclosed FSN receipt form within 10 days, acknowledging the receipt and understanding of the letter, and indicating the number of slings in use prior to inspection, the number of slings in use after the inspection, and the number of slings rejected. The accounts will be contacted for the replacement of their eligible old slings (in use up to two years).

Device

  • Modelo / Serial
    All lots of BHM/Medi-man Combi Slings released prior to 2/1/09: Part Numbers 626002, 626002M, Part 626002C, Part 626002C-M, Part 626003, Part 626003M and Part 626003X.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. || Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; || Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; || Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; || Part 626002C-M Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; || Part 626003: Combi Deluxe - Large, capacity 113-272 kg, 250-600 lbs; || Part 626003M: Combi Mesh Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. || Between 2004 and 2006, the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled Medi-Man, 100% Polyester Shell, Rehabilitation Products Inc., Mississauga, Ontario, Canada L5T 1X7, made in Canada. || The accessory is intended to be used with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    B.H.M. Medical, Inc., 2001 Tanguay Street, Magog Canada
  • Source
    USFDA