The Recall Desk
HighFDA (Devices)·Z-2735-2020·Announced 2020-08-12

Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Delivery

Smiths Medical is recalling Medfusion Syringe Pump Model 3500 units because inaccurate delivery can occur after an interrupted Bolus or Loading dose.

What this means for you

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 involves a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Smiths Medical ASD Inc. is recalling 17,019 units of the Medfusion Syringe Pump Model 3500, Software Version V6.0. The recall affects specific model numbers including 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, and 3500-0600-82. These infusion pumps were distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East.

The recall is issued because inaccurate delivery can occur following an interrupted Bolus or Loading dose if a specific sequence of events occurs. This potential for inaccurate medication delivery poses a risk to patient safety in clinical settings.

Healthcare facilities and users should contact Smiths Medical ASD Inc. for instructions on how to address the issue. The source text does not specify a particular action for consumers, as these are medical devices used by professionals.

The recalled product

Product
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
17,019

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 (6)

  • Model Numbers: 3500-0600-00
  • 3500-0600-01
  • 3500-0600-249
  • 3500-0600-50
  • 3500-0600-51
  • 3500-0600-82. Software Version V6.0

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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