• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 26
  • Fabricante 14
  • Evento 124969
  • Implante 0
1000 ml Canister (with Gel) for InfoV.A.C.® and V.A.C.ULTAT Therapy Systems
  • Modelo / Serial
  • Descripción del producto
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
    KCI International Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de 1000 ml Canister (with Gel) for InfoV.A.C.® and V.A.C.ULTAT Therapy Systems
300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
  • Modelo / Serial
    300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System Part number M8275059/5Lot Numbers: 2590876 (expiry date 11/2016) and 2590877 (expiry date 01/2017) ARTG Number: 226774
  • Manufacturer
    KCI Medical Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de 300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
500ml Canister/InfoV.A.C.
  • Modelo / Serial
  • Descripción del producto
    Injections / Infusions / Transfusions / Dialysis
  • Manufacturer
    KCI
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de 500ml Canister/InfoV.A.C.
ArjoHuntleigh BariAir Therapy System
  • Modelo / Serial
    Model: 405500, Affected: BKPK00034
  • Manufacturer
    KCI USA Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ArjoHuntleigh BariAir Therapy System
Device Recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System
  • Modelo / Serial
    Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Japan and Australia
  • Descripción del producto
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System
Device Recall CelluTome
  • Modelo / Serial
    Part number CT-H25 with the following lot numbers: 3244680000, 3446210000, 3246280000, 3246480000, 3246490000, 3246970000, 3247020000, 3247030000, 3247130000, 3247440000, 3247670000, 3247680000, 3247980000, 3248070000, 3248200000, 3248300000, 3249120000, 3249130000, 3249140000, 3249150000, 3249160000.  Part number CT-H50 with the following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000, 3245680000, 3246270000, 3246490000, 3246690000, 3246700000, 3246940000, 3246980000, 3247140000, 3247160000, 3247170000, 3247250000, 3247310000, 3247470000, 324780000, 3247810000, 3247820000, 3247960000, 3247970000, 3248080000, 3248190000, 3248230000, 3248300000, 3248380000, 3248960000, 3248970000, 3248980000, 3248990000, 3249000000, 3249010000, 3249020000, 3249030000, 3249040000, 3249050000, 3249060000, 3249070000, 3249080000, 3249090000, 3249100000, 3249110000, 3249390000, 3249580000.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US nationwide Distribution
  • Descripción del producto
    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
  • Manufacturer
    KCI USA, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CelluTome
Device Recall CelluTome
  • Modelo / Serial
    CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom.
  • Descripción del producto
    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 || The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CelluTome
Device Recall PRE1001: Prevena Peel and Place System Kit
  • Modelo / Serial
    Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE1001: Prevena Peel and Place System Kit || Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE1001: Prevena Peel and Place System Kit
Device Recall PRE1001US: Prevena Peel and Place System Kit (USONLY)
  • Modelo / Serial
    Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) || Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE1001US: Prevena Peel and Place System Kit (USONLY)
Device Recall PRE1055: Prevena Dressing, 5 Pack
  • Modelo / Serial
    Kit Lot #'s 2373868, 2397890, 2407867, 2410931, 2417878, 2417880
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE1055: Prevena Dressing, 5 Pack || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE1055: Prevena Dressing, 5 Pack
Device Recall PRE1055US: Prevena Dressing, 5 Pack (USONLY)
  • Modelo / Serial
    Kit Lot #'s 2373869, 2375897, 2382870, 2397889, 2410932
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE1055US: Prevena Dressing, 5 Pack (USONLY)
Device Recall PRE2001: Prevena Incision Management Customizable System Box
  • Modelo / Serial
    Kit Lot #'s 2383867, 2397883
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE2001: Prevena Incision Management Customizable System Box || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE2001: Prevena Incision Management Customizable System Box
Device Recall PRE2001US: Prevena Incision Management Customizable System Box (USONLY)
  • Modelo / Serial
    Kit Lot #'s 2367883, 2383868, 2397882, 2410914
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE2001US: Prevena Incision Management Customizable System Box (USONLY)
Device Recall PRE2055: Prevena Customizable Dressing 5Pack
  • Modelo / Serial
    Kit Lot # 2410919
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE2055: Prevena Customizable Dressing 5-Pack || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE2055: Prevena Customizable Dressing 5Pack
Device Recall PRE2055US: Prevena Customizable Dressing 5Pack (USONLY)
  • Modelo / Serial
    Kit Lot # 2410918
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRE2055US: Prevena Customizable Dressing 5Pack (USONLY)
KCI Prevena Incision Management System
  • Modelo / Serial
    Model: PRE101, Affected:
  • Manufacturer
    KCI USA Inc
  • 1 Event
    • Retiro De Equipo (Recall) de KCI Prevena Incision Management System
Negative Pressure Wound Therapy Systems
  • Modelo / Serial
    51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
  • Descripción del producto
    1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). || The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister
  • Manufacturer
    KCI USA, INC.
  • 1 Event
    • Retiro De Equipo (Recall) de Negative Pressure Wound Therapy Systems
RELEASE* Non-Adherent Absorbent Dressing
  • Modelo / Serial
  • Descripción del producto
    RELEASE* Non-Adherent Absorbent Dressing
  • Manufacturer
    Systagenix
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de RELEASE* Non-Adherent Absorbent Dressing
the TOPPER® Xtra Absorbent Dressing Pads
  • Modelo / Serial
  • Descripción del producto
    Dressings / Pads - swabs, sponges, wipes, swabsticks
  • Manufacturer
    Systagenix Wound Management
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de the TOPPER® Xtra Absorbent Dressing Pads
Tielle S Hydrocell Dressing
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Systagenix Wound Management Limited
  • 1 Event
    • Retiro De Equipo (Recall) de Tielle S Hydrocell Dressing
Topper Xtra absorbent
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Systagenix
  • 1 Event
    • Retiro De Equipo (Recall) de Topper Xtra absorbent
TOPPER Xtra Absorbent Dressing Pad
  • Modelo / Serial
  • Manufacturer
    Systagenix Wound Management
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de TOPPER Xtra Absorbent Dressing Pad
TOPPER Xtra Absorbent Dressing Pad Model: M11121N,Ml1131,Mlll41,P55263,P55264,P55255
  • Modelo / Serial
    All
  • Descripción del producto
    MD: Non-woven gauze pad, sterile
  • Manufacturer
    Systagenix Wound Management
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de TOPPER Xtra Absorbent Dressing Pad Model: M11121N,Ml1131,Mlll41,P55263,P55264,P55255
TOPPER Xtra Absorbent Dressing Pads, Sterile
  • Modelo / Serial
    TOPPER Xtra Absorbent Dressing Pads, Sterile Product codes: P55263 and P55264 – all pack sizesAll lots affectedARTG number: 168750
  • Manufacturer
    KCI Medical Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de TOPPER Xtra Absorbent Dressing Pads, Sterile
V.A.C. GranuFoam Silver Dressing
  • Modelo / Serial
    Lot Number 50775911
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
  • Descripción del producto
    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
  • Manufacturer
    KCI USA, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de V.A.C. GranuFoam Silver Dressing
  • 1
  • 2
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.