The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs."

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 →

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