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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4XD0F, T4XK71
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KBW16.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4VU41, T4VY0X, T4W345, T4W346, T4WY38, T4X059, T4X33K, T4YC9Z, T4YE00.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL22.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4WF6D, T4WT8Y, T4X52J, T4Y03E.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    General Laparoscopic Tray, Product #TGL33.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4WP5P
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    General Laparoscopic Tray, Product #TGL53.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4YD0G
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4VN3C, T4W02R, T4W76M, T4WA05, T4WK2N, T4X33J.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    FlexTray Procedure Delivery System Endopath Gastric Tray, Product #KGB11.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4WX67, T4X22Y, T4X95D, T4XG4C, T4XK7M, T4XM7U, T4XY24, T4Y32W.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL45.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
Device Recall Salvart Oral Moisturizer
  • Modelo / Serial
    Lots: #031751F09, #031761F10, #031771F11. Expiration date for all lots: June 2005.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to consignees located nationwide.
  • Descripción del producto
    Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
  • Manufacturer
    Gebauer Co
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Salvart Oral Moisturizer
Aquasorb ¿ Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets p...
  • Modelo / Serial
    Lot 360025
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Product was sold to 3 distributors in CA, OH and PA.
  • Descripción del producto
    Aquasorb ¿ Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
  • Manufacturer
    DeRoyal Wound Care
  • 1 Event
    • Retiro De Equipo (Recall) de Aquasorb ¿ Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
Device Recall Nexcare HoldFast Roll Gauze
  • Modelo / Serial
    Lot # 4267. Catalog number HF-2R
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Product sent to 38 retail healthcare product distributors located throughout the US and guam. States include MN, IL, MO, CO, TX, PA, MA, MD, NJ, NY, GA, NC, SC, WA, CA and Hawaii
  • Descripción del producto
    3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling.
  • Manufacturer
    3M Company / Medical Division
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Nexcare HoldFast Roll Gauze
Device Recall Waterlase MD
  • Modelo / Serial
    Model #6200218; Serial Numbers: 10500210 to 10502680, inclusive.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
  • Descripción del producto
    Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
  • Manufacturer
    Biolase Technology Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Waterlase MD
Device Recall Clinician Workstation
  • Modelo / Serial
    Product code 2M5042, software versions 3.4, 4.0 and 4.1
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Missouri, Massachusetts, Vermont, California and Canada.
  • Descripción del producto
    Clinician Workstation Software, product code 2M5042
  • Manufacturer
    Baxter Healthcare Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Clinician Workstation
Device Recall Baxter's Patient Care System
  • Modelo / Serial
    Software version 4.1-77, 4.0-66 and 3.4-18.24
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Missouri, Massachusetts, Vermont, California and Canada.
  • Descripción del producto
    Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
  • Manufacturer
    Baxter Healthcare Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Baxter's Patient Care System
Device Recall STIC
  • Modelo / Serial
    Serial numbers 0428702183 through 0518008193.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.
  • Descripción del producto
    Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall STIC
Device Recall Baxter's Patient Care System
  • Modelo / Serial
    all units of software versions 4.0 (66) and 4.1 (77)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Missouri, Massachusetts, Vermont, California and Canada.
  • Descripción del producto
    Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
  • Manufacturer
    Baxter Healthcare Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Baxter's Patient Care System
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip...
  • Modelo / Serial
    Lot 050678 and Lot 050575.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The device is distributed nationwide to hospitals nationwide.
  • Descripción del producto
    Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape)
  • Modelo / Serial
    Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Product was distributed to direct accounts in the United States and Belgium.
  • Descripción del producto
    Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.
  • Manufacturer
    Southwest Technologies Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape)
Device Recall Medplus ER Drug Screen Test
  • Modelo / Serial
    Lot Numbers Affected: 85699 and 85671
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide (distributors in KS and OR).
  • Descripción del producto
    Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
  • Manufacturer
    Applied Biotech Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medplus ER Drug Screen Test
Device Recall OASIS Medical SOFT PLUG
  • Modelo / Serial
    Lot LA1105E
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution ----USA and countries of Chile, and United Kingdom.
  • Descripción del producto
    OASIS¿ Medical SOFT PLUG¿ Extended Duration Plug, Reference 6403 (Lot LA1105E)
  • Manufacturer
    Oasis Medical Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OASIS Medical SOFT PLUG
Device Recall Salivart Oral Moisturizer
  • Modelo / Serial
    Lot ''06AA003'', expiration date 06/08 Lot ''06AA001'', expiration date 06/08 Lot ''06AA002'', expiration date 06/08 Lot ''06AA004'', expiration date 07/08 Lot ''06AA005'', expiration date 07/08 Lot ''06AA006'', expiration date 10/08 Lot ''06AA007'', expiration date 10/08
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and medical facilities) and full size samples of product were given away at trade shows to medical, and dental offices and some end users consumers). A total of 240 units of product derived from Lot Code: 06AA001, were distributed to a single Canadian distributor under the assigned Lot Code: 06BB002
  • Descripción del producto
    Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Salivart Oral Moisturizer
Device Recall ProWick Shoulder Postoperative Dressing and Cold Therapy System
  • Modelo / Serial
    Lot number: D632517
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
  • Manufacturer
    Integra Biotechnical LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ProWick Shoulder Postoperative Dressing and Cold Therapy System
Churchill Medical Systems
  • Modelo / Serial
    Lot Numbers: 10J29, 10J55, 11A18, 11A47 and 11B06.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    United States (FL, MA, MD, and VA).
  • Descripción del producto
    Churchill Medical Systems || AMS-7080CP (Dressing Change Kit). || The device intended use is a dressing change kit.
  • Manufacturer
    Vygon Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Churchill Medical Systems
Churchill Medical Systems
  • Modelo / Serial
    Lot Numbers: 10I60, 10K42 and 10F87.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    United States (FL, MA, MD, and VA).
  • Descripción del producto
    Churchill Medical Systems || AMS-8316CP-1 (Central Line Dressing Kit). || The device intended use is a central line dressing kit.
  • Manufacturer
    Vygon Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Churchill Medical Systems
Churchill Medical Systems
  • Modelo / Serial
    Lot Number: 10H30.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    United States (FL, MA, MD, and VA).
  • Descripción del producto
    Churchill Medical Systems AMS-8431CP (PICC insertion Tray). || The device intended use is a PICC insertion tray.
  • Manufacturer
    Vygon Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Churchill Medical Systems
Churchill Medical Systems
  • Modelo / Serial
    AMS-9189CP-1, Lot Numbers: 1006150, 1006149 and 1008143. AMS-9189CP, Lot Number: 1003527.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    United States (FL, MA, MD, and VA).
  • Descripción del producto
    Churchill Medical Systems || AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. || Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. || The devices intended use is a Dressing Change Kit.
  • Manufacturer
    Vygon Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Churchill Medical Systems
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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.