Atlas FDA

MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP

FDA 510(k) clearance K040899 · decided 2004-04-30

Clearance details

K-number
K040899
Device name
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
Applicant
Medex, Inc.
Decision
Substantially Equivalent
Date received
2004-04-06
Decision date
2004-04-30
Days to decision
24 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Dublin, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c recall (Z-1540-2024)Smiths Medical ASD Inc.2024-04-15
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, recall (Z-1542-2024)Smiths Medical ASD Inc.2024-04-15
smiths medical Medfusion Model 3500 Syringe pump recall (Z-0863-2024)Smiths Medical ASD Inc.2024-02-01
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 recall (Z-0076-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 recall (Z-0077-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51 recall (Z-0078-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe recall (Z-0653-2022)Smiths Medical ASD Inc.2022-02-17
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 recall (Z-2734-2020)Smiths Medical ASD Inc.2020-08-06
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. recall (Z-2735-2020)Smiths Medical ASD Inc.2020-08-06
Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for recall (Z-1135-2018)Smiths Medical ASD Inc.2018-03-05
Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated for recall (Z-1136-2018)Smiths Medical ASD Inc.2018-03-05
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in criti recall (Z-0996-2013)Smiths Medical ASD, Inc.2013-03-26
Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps recall (Z-1206-2012)Smiths Medical ASD, Inc.2012-03-14
MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3 recall (Z-2121-2010)Smiths Medical ASD, Inc.2010-08-02
Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model recall (Z-0650-2010)Smiths Medical ASD, Inc.2010-01-15
Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Med recall (Z-0651-2010)Smiths Medical ASD, Inc.2010-01-15
Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A smal recall (Z-1018-2009)Smiths Medical MD, Inc.2009-03-09
Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A smal recall (Z-1019-2009)Smiths Medical MD, Inc.2009-03-09