Smiths Medical ASD Inc.: 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.

Recall number

Z-1135-2018

Recalling firm

Smiths Medical ASD Inc.

Product

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.

Status

Terminated

Initiated

2017-11-13

Posted

2018-03-05

Terminated

2025-09-16

Reason

Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.

Root cause

Process change control

Action

Consignees were notified via mail on 11/13/2017, 01/09/2018, and 02/12/2018, as a result of expansions of the recall and the need to provide additional instructions and information to consignees. Instructions in the first letter date 11/13/2017 instructed customers to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to utilize the enclosed Reference Tool when verifying syringe size, and to complete the return the Response Form. Instructions in the letter dated 01/09/2018 included to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to advise all clinicians overseeing use of the affected devices to utilize the enclosed Reference Tool, to remove the pump if the syringe is not recognized or is read as an incorrect size during programming or infusion, to notify impacted customers if the devices were further distributed, and to complete the return the Response Form. Instructions in the letters dated 02/12/2018 included to identify any affected devices on hand, complete and return the Urgent Medical Device Recall Response Form, and arrange for repair of the affected as per the location of the consignee in Canada or the USA. If the consignee is located in the USA, the three options include to return to Smiths Medical for repair, arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair, or arrange for onsite repair by Smiths Medical if there are more than 10 pumps onsite. If the consignee is located in Canada, the two options include to return to Smiths Medical for repair or arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair. Consignees not located in the USA or Canada were instructed to contact their Smiths Medical Representative to discuss repair options. For further questions, please send inquiries to SmithsMedical3033@stericycle.com.

Quantity

16,600 pumps total

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.

Lot, serial or model codes

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

510(k) numbers

["K040899"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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