Agency classClass IIOur severity:High FDA (Devices)·Z-1136-2018·Announced 2018-03-28

Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues

Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Smiths Medical ASD Inc. is recalling certain Medfusion Syringe Pump models from the 3100, 3500, and 4000 series. The recall involves 16,600 pumps that were distributed worldwide, including in the United States, Australia, Canada, and the United Kingdom.

The recall is being issued because these pumps may not recognize or may misidentify loaded medication syringes. If the pump cannot recognize the syringe, it cannot complete the programming process. If the pump misidentifies the syringe, it may incorrectly interpret the syringe size. These issues could affect the administration of fluids requiring precisely controlled infusion rates.

Healthcare facilities and users of these devices should contact Smiths Medical ASD Inc. for further instructions on how to address the issue. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 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…
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Infusion Pumps
Hazard: device-malfunction
medication-error
Affected units: 16,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Smiths Medical ASD Inc.

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