The Recall Desk
CriticalFDA (Devices)·Z-2734-2020·Announced 2020-08-12

Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery

Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which corresponds to a reasonable probability of serious adverse health consequences or death, mandating a Critical severity score per the rubric.

Plain-English summary

Smiths Medical ASD Inc. is recalling Medfusion Syringe Pump Model 4000 units equipped with software versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1. The recall involves 35,616 units that were distributed worldwide, including in the United States, Canada, and various countries in Europe, Asia, and the Middle East.

The recall is being conducted because inaccurate delivery can occur following an interrupted Bolus or Loading dose if a specific sequence of events occurs. This defect poses a risk of patients receiving incorrect medication dosages.

Healthcare facilities and consumers should contact Smiths Medical ASD Inc. for instructions on how to address this issue. The agency has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Syringe Pump
Hazard
Affected units
35,616

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 (10)

  • Model Numbers: 4000-0105-249
  • 4000-0105-50
  • 4000-0105-51
  • 4000-0105-78
  • 4000-0106-00
  • 4000-0106-01
  • and 4000-0106-231. Software Versions V1.5.0
  • V1.5.1
  • V1.6.0
  • and V1.6.1

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

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