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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
0.2 Micron Flat Epidural Filter
  • Modelo / Serial
    Lot Numbers:  13F17D0240 13F17G0371 13F17K0408
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
  • Descripción del producto
    0.2 Micron Flat Epidural Filter; Product Code: EF-05500
  • Manufacturer
    Arrow International Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 0.2 Micron Flat Epidural Filter
0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile
  • Modelo / Serial
    CODES: KH04103, KH04104, KH04105
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in states of:OH, PA, AL, IL, TN, and CT.
  • Descripción del producto
    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 || Usage: Flush syringe.
  • Manufacturer
    MRP, LLC dba AMUSA
  • 1 Event
    • Retiro De Equipo (Recall) de 0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile
0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 10 mL in 12 mL Single Use Syringe
  • Modelo / Serial
    KH03752
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to one customer in Illinois.
  • Descripción del producto
    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. || Flush syringe.
  • Manufacturer
    Amsino Medical USA
  • 1 Event
    • Retiro De Equipo (Recall) de 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 10 mL in 12 mL Single Use Syringe
0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe
  • Modelo / Serial
    KH03752
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to one customer in Illinois.
  • Descripción del producto
    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. || Flush syringe.
  • Manufacturer
    Amsino Medical USA
  • 1 Event
    • Retiro De Equipo (Recall) de 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe
100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 5...
  • Modelo / Serial
    Lots D316302 and D323912.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CO, PA,
  • Descripción del producto
    100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102
  • Manufacturer
    Maximus Medical Products Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102
100 mL Hemovac Mini Evacuator
  • Modelo / Serial
    Item #00-2568-000-10; Lot #62800843
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
  • Descripción del producto
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. || Intended for post-operative collection of wound drainage.
  • Manufacturer
    Zimmer Surgical Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 100 mL Hemovac Mini Evacuator
10.5CM ANGLE ATTACHMENT, BLACK MAX
  • Modelo / Serial
    All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11-S.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Descripción del producto
    10.5CM ANGLE ATTACHMENT, BLACK MAX
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 10.5CM ANGLE ATTACHMENT, BLACK MAX
10.5cm Long Attachment
  • Modelo / Serial
    All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-S.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Descripción del producto
    10.5cm Long Attachment || Product Usage: || Pneumatic system
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 10.5cm Long Attachment
10.5cm Long Attachment, NonTapered End
  • Modelo / Serial
    All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-01.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Descripción del producto
    10.5cm Long Attachment, Non-Tapered End || Product Usage: || Pneumatic system
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 10.5cm Long Attachment, NonTapered End
10.5cm QD Angle Attachment
  • Modelo / Serial
    All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11-S.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Descripción del producto
    10.5cm QD Angle Attachment || Product Usage: || Pneumatic system
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 10.5cm QD Angle Attachment
10 cc LuerSlip Loss of Resistance Syringe
  • Modelo / Serial
    Lot Numbers:  13F17C0328 13F17F0296 13F17G0202 13F17H0104 13F17J0207
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
  • Descripción del producto
    10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
  • Manufacturer
    Arrow International Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 10 cc LuerSlip Loss of Resistance Syringe
10 FR Super ArrowFlex Percutaneous Sheath Introducer Set
  • Modelo / Serial
    Catalog/Model number CL-07011, Lot number CF03075226
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka
  • Descripción del producto
    10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
  • Manufacturer
    Arrow International Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 10 FR Super ArrowFlex Percutaneous Sheath Introducer Set
10 NBF
  • Modelo / Serial
    Product Code: C4320-450B Lot Number: 300403
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Cardinal Health Prefilled Buffered 10% Formalin. || Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
10 NBF
  • Modelo / Serial
    Product Code: 426-796 Lot Number: 298987
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Protocol 10% NBF || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
10 NBF
  • Modelo / Serial
    Product Code: 534801 Lot Number: 296986
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Richard-Allan Scientific Specimen Transportation System. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
10 NBF
  • Modelo / Serial
    Product Code: LC-0060 Lot Number: 300445
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Richard-Allan Scientific 10% Neutral Buffered Formalin. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
10 NBF
  • Modelo / Serial
    Product Code: 59601 Lot Number: 300233
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Richard-Allan Scientific Bio-Tite Specimen Containers. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
10 NBF
  • Modelo / Serial
    Product Code: 51401 Lot Number: 300649
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Richard-Allan Scientific 10% Neutral Buffered Formalin. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
10 NBF
  • Modelo / Serial
    Product Code: 53151 Lot Number: 300143
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • Descripción del producto
    Richard-Allan Scientific Specimen Transportation System. || 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de 10 NBF
1100 Series Aluminum Retractors
  • Modelo / Serial
    Lot #6000 (Serial numbers: 1480 thru 1489); Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); & Lot #6155 (Serial numbers: 1540 thru 1559).
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
  • Descripción del producto
    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.
  • Manufacturer
    Lone Star Medical Products, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 1100 Series Aluminum Retractors
1100 Series Aluminum Retractors
  • Modelo / Serial
    Lot #5869 (Serial numbers: 5193 thru 5200, 5207 thru 5211 and 5213 thru 5229); Lot #5924 (Serial numbers: 5244, 5245, 5254, 5256 thru 5260, 5169, 5172, 5181, 5152, and 5185 thru 5187); & Lot #5982 (Serial numbers: 5148, 5176, 5183, 5184, 5188, 5192, 5204, 5206, 5253 and 5255).  Serial numbers: , ;
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
  • Descripción del producto
    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.
  • Manufacturer
    Lone Star Medical Products, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 1100 Series Aluminum Retractors
1100 Series Aluminum Retractors
  • Modelo / Serial
    Lot #5868 (Serial numbers: 7558 thru 7565); Lot #5890 (Serial numbers: 5230 thru 5243 and 7548) & Lot #5923 (Serial numbers: 7533, 7536, 7539, 7543 thru 7545, 7548 and 7549).
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
  • Descripción del producto
    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.
  • Manufacturer
    Lone Star Medical Products, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 1100 Series Aluminum Retractors
11.0cm Long Attachment
  • Modelo / Serial
    All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Descripción del producto
    11.0cm Long Attachment || Product Usage: || Pneumatic system
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 11.0cm Long Attachment
11.25CM ATTACHMENT, BLACK MAX
  • Modelo / Serial
    All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLUE-S.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Descripción del producto
    11.25CM ATTACHMENT, BLACK MAX
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 11.25CM ATTACHMENT, BLACK MAX
115V Blanketroll III Model 233 and 115V CoolBlue Model 2501
  • Modelo / Serial
    Model 233, Serial Numbers 061-3-00001 through 101-3-01389 and Model 25-01, Serial Numbers 073-CB-00001 through 094-CB-00138.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, 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, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.
  • Descripción del producto
    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. || Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 115V Blanketroll III Model 233 and 115V CoolBlue Model 2501
  • 1
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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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