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Vista de la lista Vista de las tarjetas
  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Neptune Plus, hemostasis pad
  • Modelo / Serial
    Lot Numbers:  AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US nationwide distribution.
  • Descripción del producto
    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
  • Manufacturer
    TZ Medical Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Neptune Plus, hemostasis pad
XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device
  • Modelo / Serial
    Lot BMZCE039, Expiration Date 2018-12-31
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
  • Descripción del producto
    X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 || The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
  • Manufacturer
    C.R. Bard, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device
Softbank II 23.1.2.8 25.3.0.0
  • Modelo / Serial
    Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
  • Descripción del producto
    SCC Soft Computer Softbank II software || Product Usage: || Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
  • Manufacturer
    Soft Computer Consultants, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Softbank II 23.1.2.8 25.3.0.0
Softbank 25.5.2.025.5.3.1
  • Modelo / Serial
    Version: 35.5.2.0, 25.5.3.0, 25.5.3.1
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
  • Descripción del producto
    Softbank software || Product Usage: || Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
  • Manufacturer
    Soft Computer Consultants, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Softbank 25.5.2.025.5.3.1
Vision (tm)
  • Modelo / Serial
    Versions 6.1 and 6.5
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Software was distributed to end users nationwide and internationally.
  • Descripción del producto
    BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
  • Manufacturer
    Varian Brachytherary Virginia
  • 1 Event
    • Retiro De Equipo (Recall) de Vision (tm)
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro S...
  • Modelo / Serial
    Lot 050-779, Model # 1523211; Lot 050-779, Model # 1523215.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product is distributed directly to the firm''s sales representatives and direct accounts.
  • Descripción del producto
    Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
DStat Dry Hemostatic adhesive bandage
  • Modelo / Serial
    301322, 301323, 301359, 301323A, 301393 and 301360
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom
  • Descripción del producto
    D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Adhesive bandage
  • Manufacturer
    Vascular Solutions, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de DStat Dry Hemostatic adhesive bandage
DStat Dry Hemostatic Bandage
  • Modelo / Serial
    Lot numbers 301323A and 301393
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI.
  • Descripción del producto
    D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
  • Manufacturer
    B. Braun Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de DStat Dry Hemostatic Bandage
Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Set
  • Modelo / Serial
    order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore
  • Descripción del producto
    Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078
  • Manufacturer
    Abbott Molecular
  • 1 Event
    • Retiro De Equipo (Recall) de Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Set
DStat Radial Hemostat Band
  • Modelo / Serial
    301384, 301385 and 301386
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom
  • Descripción del producto
    D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad.
  • Manufacturer
    Vascular Solutions, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de DStat Radial Hemostat Band
DStat Radial Hemostat Band
  • Modelo / Serial
    301404
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom
  • Descripción del producto
    D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic bandage (D-Stat 2 Dry) consists of the following components: -One (1) scored lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride; -Two (2) Adhesive bandages.
  • Manufacturer
    Vascular Solutions, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de DStat Radial Hemostat Band
Spectra Optia
  • Modelo / Serial
    Part No. 61000, Serial Numbers 1P00100 to 1P00141.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US, Canada, Australia, Europe.
  • Descripción del producto
    Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
  • Manufacturer
    Gambro BCT, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Spectra Optia
FluroEthyl.
  • Modelo / Serial
    Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de FluroEthyl.
Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1,
  • Modelo / Serial
    Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada
  • Descripción del producto
    Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Dates: || 4.0.2.38.1 06/15/07 || 4.02.39.2 06/29/07, || 4.02.40.1 07/19/07, || 4.02.41.1 08/20/07. || The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1,
Fresenius Red Blood Cell Set (RBC)
  • Modelo / Serial
    Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.
  • Descripción del producto
    Fresenius Red Blood Cell Set, Catalog Number 9007601. || The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". || Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
  • Manufacturer
    Fresenius Kabi, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Fresenius Red Blood Cell Set (RBC)
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