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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems
  • Modelo / Serial
    Catalog Number: 03260925184; Lot Numbers & Exp. Dates:   1. 21450781, Exp. 08/31/2016 2. 21450887, Exp. 08/31/2016 3. 21451391, Exp. 09/30/2016
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.
  • Descripción del producto
    S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 || Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems
Device Recall Olympus
  • Modelo / Serial
    Serial Numbers: 2807123,2706168,2704697,2704696,2706205,2603823,2500832,2806683,2706253, 2706256,2704313,2704314,2008421,2602202,2602873,2806818,2704323,2603826, 2806676,2807264,2603013,2602S15,2501708,2806563,2501622,2602650,2501251, 2704932,2501637,2705315,2208812,2603725,2806595,2601980,2500885,2603935, 2705615,2705705,2705305,2500522,2907865,2705498,2603941,2807163,2807143, 2501819,2704886,2501553,2501744,2501768,2603178,2603044,2704755,2501372, 2807593,2705425,2208838,2208833,2706176,2008309,2704655,2705847,2706206, 2603321,2705005,2501169,2704832,2704839,2602446,2806333,2705983,2500287, 2601941,2501912,2604229,2501770,2806741,2806744,2603057,2704336,2806592, 2500217
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) and in Australia.
  • Descripción del producto
    Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
  • Manufacturer
    Integrated Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Olympus
Device Recall Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and...
  • Modelo / Serial
    LLS projectors
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    US Distribution
  • Descripción del producto
    X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 || High-power laser light show projector.
  • Manufacturer
    X-Laser Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models
Sams Modular Perfusion System 8000
  • Modelo / Serial
    catalog number: 16406 serial numbers: 1001-1004,1007-1055,1057-1310, 1648, 1649, 1657, 1822, and 1823.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).
  • Descripción del producto
    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included || The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Sams Modular Perfusion System 8000
Dr Mullins Kit
  • Modelo / Serial
    Lot Numbers/Expiration Dates:  65805 2/24/2015 59138 8/31/2015 61015 9/17/2015 65118 10/20/2015 65413 11/3/2015 66234 11/8/2015 66921 11/29/2015 57959 8/15/2016 69802 9/27/2016 68607 10/5/2016 71901 10/19/2016 71111 12/26/2016 72510 3/14/2017 76252 4/14/2017 76892 4/23/2017 74517 5/15/2017 73799 5/24/2017 75239 7/15/2017 77363 8/25/2017
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
  • Descripción del producto
    Dr Mullins Kit, kit number PSS1861(A || convenience custom kits used for general surgery in hospital operating room
  • Manufacturer
    Windstone Medical Packaging, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Dr Mullins Kit
BD AutoShield Pen Needle
  • Modelo / Serial
    Reorder Number 329300
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
  • Descripción del producto
    BD AutoShield Pen Needle (Re order Number : 329300)
  • Manufacturer
    Becton Dickinson & Company
  • 1 Event
    • Retiro De Equipo (Recall) de BD AutoShield Pen Needle
King Systems Universal Flex2 Breathing Circuit
  • Modelo / Serial
    Lots IKLX0, IKME5, IKVB2 and IKZ38.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.
  • Descripción del producto
    King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF4110-6121Z. || This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
  • Manufacturer
    King Systems Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de King Systems Universal Flex2 Breathing Circuit
Device Recall VenaCure EVLT
  • Modelo / Serial
    Batch/Lot Numbers: 549595, 549617, 550212, 551109, 552005, 552052, 552968, 553310, 554282, 554283, 554642
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore
  • Descripción del producto
    VenaCure EVLT¿ NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
  • Manufacturer
    Angiodynamics Worldwide Headquarters
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VenaCure EVLT
Device Recall Symbiq Two Channel Infuser
  • Modelo / Serial
    List Number 16027-01, all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
  • Descripción del producto
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 || Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
  • Manufacturer
    Hospira Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Symbiq Two Channel Infuser
Device Recall da Vinci 5 mm Flared Instrument Cannulae
  • Modelo / Serial
    Model number 420262
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
  • Descripción del producto
    da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. || Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
  • Manufacturer
    Intuitive Surgical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall da Vinci 5 mm Flared Instrument Cannulae
Device Recall Customed
  • Modelo / Serial
    Product code 900-1482, 39 lots: 110102428 110112608 110123088 111010049 111020265 111030581 111040888 111051317 111061497 111071865 111082190 111092354 111102683 111113009 111123347 112010050 112020371 112030620 112041188 112051766 112062419 112083396 112093898 112124950 112125282 113025940 113036669 113047197 113067888 113068256 113078256 113109732 131210747 140111083 140211641 140312070 140312453 140513090 140613609
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    E..N.T. PACK - || (5) SPONGE TONSIL 7/8 XRD || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED L/F || (1) TUBE SUCTION CONNECT %" X 12' L/F || (1) CAUTERY TIP POLISHER LIF || (1) SUTURE BAG FLORAL || (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) CAUTERY PENCIL HAND SWITCHING || (2) ABSORBENT TOWELS 15" X 20" L/F || (1) DRAPE SHEET 41 " X 58" SMS L/F || (1) EAR/ULCER SYRINGE 2oz LIF || (2) MEDICINE CUP 2oz || (1 0) GAUZE SPONGE 4" X 4" 16PL Y || (1) *Pr. SURGICAL GLOVES #7% POWDER || (1) *Pr. SURGICAL GLOVES #7 POWDER || (9) LABEL FOR SKIN MARKER || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Customed
Device Recall IMHS CP
  • Modelo / Serial
    Lot Number: 08K22270
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution to USA, Switzerland and Australia.
  • Descripción del producto
    IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
  • Manufacturer
    Smith & Nephew Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall IMHS CP
Device Recall Hospira Primary I.V. set
  • Modelo / Serial
    Lot numbers: 610444W and 620154W.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Descripción del producto
    Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 8962-48.
  • Manufacturer
    Hospira Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Hospira Primary I.V. set
Synthes Implant Holder for Synfix (TM)LR
  • Modelo / Serial
    all lots of part no. 03.802.039
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada .
  • Descripción del producto
    Synthes Implant Holder for Synfix (TM)-LR || the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
  • Manufacturer
    Synthes USA HQ, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Synthes Implant Holder for Synfix (TM)LR
Hospitak
  • Modelo / Serial
    Product ID # 735-E; lot codes: 03-05 03-15 03-28 04-06 04-26 04-33 05-43 05-44 05-47 07-34; 04-19 04-37 05-07 05-09 05-19 06-09 06-20 06-34 07-04 07-34 Argentina: 03-14;  Japan: 06-29; Mexico: 02-29 02-42 03-15 03-17    Distributed in France only: product code: 40-116735, lot codes: 04-34 04-38 04-45 04-50 06-43
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
  • Descripción del producto
    Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.
  • Manufacturer
    Unomedical
  • 1 Event
    • Retiro De Equipo (Recall) de Hospitak
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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.

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