Events

Retiro De Equipo (Recall) de Device Recall CareFusion

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 Instrumed International, 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
    68725
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2724-2014
  • Fecha de inicio del evento
    2014-05-30
  • Fecha de publicación del evento
    2014-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128738
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Additional caution statements have been added to the instructions for use for monopolar electrodes. 1) to avoid tissue carbonation, the operation voltage of the hf generator must not exceed 650 peak voltage (vp) for all monopolar electrodes. and 2) for all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
  • Acción
    Instrumed sent an URGENT: MEDICAL DEVICE CORRECTION letters dated May 30, 2014 to all consignees. The letters advised the consignees of the new warning statements on the product Instructions For Use and an instruction to complete and return the attached Response Request Form to Instrumed International. Consignees were further instructed to extend the recall to the retail level. For questions contact Instrumed Quality Manager at 847-908-6119.

Device

Device Recall CareFusion
  • Modelo / Serial
    1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111;  2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ; Lot Number: 070211, 070213, 090412;  3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209;  4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number: 030511, 040310, 080111;  5) Instrumed Item No.: 250-08630; CareFusion Catalog Code: LA8515-45; Lot Number: 050212;  6) Instrumed Item No.: 250-08660; CareFusion Catalog Code: LA8514; Lot Number: 040110;  7) Instrumed Item No.: 250-08670; CareFusion Catalog Code: LA8514-45; Lot Number: 120410;  8) Instrumed Item No.: 250-08680; CareFusion Catalog Code: LA8526; Lot Number: 010313, 060311, 060312;  9) Instrumed Item No.: 250-08690; CareFusion Catalog Code: LA8526-45; Lot Number: 030314, 100410, 120110, 120312;  10) Instrumed Item No.: 250-08700; CareFusion Catalog Code: LA8518; Lot Number: 060111, 070110, 080211;  11) Instrumed Item No.: 250-08710; CareFusion Catalog Code: LA8518-45; Lot Number: 010114, 040113, 040313, 060410;  12) Instrumed Item No.: 250-08730; CareFusion Catalog Code: LA8520-45; Lot Number: 010213;  13) Instrumed Item No.: 250-08740; CareFusion Catalog Code: LA8519; Lot Number: 060108, 080310;  14) Instrumed Item No.: 250-08760; CareFusion Catalog Code: LA8521; Lot Number: 020212, 060113, 060213, 100513, 121410;  15) Instrumed Item No.: 250-08770; CareFusion Catalog Code: LA8521-45; Lot Number: 100210;  16) Instrumed Item No.: 250-08780; CareFusion Catalog Code: LA8513; Lot Number: 010110, 050313, 070112, 122110;  17) Instrumed Item No.: 250-08790; CareFusion Catalog Code: LA8513-45; Lot Number: 090411, 100309, 100312;  18) Instrumed Item No.: 250-08800; CareFusion Catalog Code: LA8525; Lot Number: 040114, 090410, 110310, 120111;  19) Instrumed Item No.: 250-08810; CareFusion Catalog Code: LA8525-45; Lot Number: 050308, 060310;  20) Instrumed Item No.: 250-08820; CareFusion Catalog Code: LA8517; Lot Number: 110410, 120212;  21) Instrumed Item No.: 250-08860; CareFusion Catalog Code: LA8507; Lot Number: 011111, 020111, 030210, 041411, 060112, 060313, 070312, 070712, 100413, 100512, 110112, 110313, 110413;  22) Instrumed Item No.: 250-08880; CareFusion Catalog Code: LA8507-45; Lot Number: 061011, 070313, 070513;  23) Instrumed Item No.: 250-08890; CareFusion Catalog Code: LA8506; Lot Number: 020211, 020410;  24) Instrumed Item No.: 250-08900; CareFusion Catalog Code: LA8506-45; Lot Number: 050407;  25) Instrumed Item No.: 250-08930; CareFusion Catalog Code: LA8505; Lot Number: 010314, 010513, 010611, 030113, 032211, 040112, 090313, 100111, 120710;  26) Instrumed Item No.: 250-08960; CareFusion Catalog Code: LA8505-45; Lot Number: 30313, 090113, 110110, 120211;  27) Instrumed Item No.: 250-08970; CareFusion Catalog Code: LA8504; Lot Number: 050110, 080510;  28) Instrumed Item No.: 250-08980; CareFusion Catalog Code: LA8504-45; Lot Number: 050311;  29) Instrumed Item No.: 250-08990; CareFusion Catalog Code: LA8503; Lot Number: 020414, 042310, 110411;  30) Instrumed Item No.: 250-09000; CareFusion Catalog Code: LA8503-45; Lot Number: 020512;  31) Instrumed Item No.: 250-09010; CareFusion Catalog Code: LA8509; Lot Number: 020413, 021511, 030211, 030212, 030G12, 03101816-;  32) Instrumed Item No.: 250-09030; CareFusion Catalog Code: LA8509-45; Lot Number: 070212;  33) Instrumed Item No.: 250-09040; CareFusion Catalog Code: LA8510; Lot Number: 040411;  34) Instrumed Item No.: 250-09070; CareFusion Catalog Code: LA8508-45; Lot Number: 050410;  35) Instrumed Item No.: 250-09100; CareFusion Catalog Code: VM46-9183; Lot Number: 060411;  36) Instrumed Item No.: 250-09120; CareFusion Catalog Code: VM46-9185; Lot Number: 090308
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Descripción del producto
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. || The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
  • Manufacturer
    Instrumed International, Inc.

Manufacturer

Instrumed International, Inc.
  • Dirección del fabricante
    Instrumed International, Inc., 626 Cooper Ct, Schaumburg IL 60173-4537
  • Empresa matriz del fabricante (2017)
    Avalign Technologies Inc.
  • Source
    USFDA