Device Recall Medfusion Syringe Pump

  • Modèle / numéro de série
    Product Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Medfusion Syringe Pump 4000 Series || The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Société-mère du fabricant (2017)
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model No. 4000; Reference No. 4000-0101-51
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Description du dispositif
    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. || In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
  • Manufacturer
  • Modèle / numéro de série
    Model No. 3500; Reference No. 3500-0600-51
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Description du dispositif
    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. || In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
  • Manufacturer
  • Modèle / numéro de série
    Product Codes 3500G, 3500VX, 3500-414, 3500-402, 3500-0600-249, 3500-0600-00, 3500-0600-01, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-415, 3500-500
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Medfusion Syringe Pump 3500 Series || The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
  • Manufacturer
  • Modèle / numéro de série
    Product Codes 3010, 3010A with Model No. M03055, M02396, M02315, M02385, M02636, M02780, M02890, M03075, M03245, M03335, M03592, M03599, M03727, M03729, M03817, M03887, M04406, M04568, M04778, M04870, M05494, M05587, M05762, M05766, M05767, M05768, M05849, M06244, M07153, M07159, M07335, M07361, M07443, M07460, M08153, M08157, M08168, M08735, M08736, M08820, M08853, M08871, M08878, M09038, M09057, M09992, M10227, M10229, M10263, M10270, M10325, M10342, M10347, M10353, M10366, M10589, M10879, M10890, M10896, M10900, M11875, M11877, M11898, M11900, M11918, M11919
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Medfusion Syringe Pump 3010 Series || The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
  • Manufacturer