Devices

Device Recall Medfusion Syringe Pump

  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Smiths Medical ASD Inc.
  • 1 Event

Manufacturer

Smiths Medical ASD Inc.
  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA

4 devices with a similar name

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Device Recall Medfusion Syringe Pump, 4000 Series
  • Model / Serial
    Model No. 4000; Reference No. 4000-0101-51
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Product Description
    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
    Smiths Medical ASD Inc.
Device Recall Medfusion Syringe Pump, 3500 Series
  • Model / Serial
    Model No. 3500; Reference No. 3500-0600-51
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Product Description
    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
    Smiths Medical ASD Inc.
Device Recall Medfusion Syringe Pump
  • Model / Serial
    Product Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Smiths Medical ASD Inc.
Device Recall Medfusion Syringe Pump
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Smiths Medical ASD Inc.