RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026MedfusionOfficial source

    Medfusion 3500 and 4000 Syringe (2020-08-20)

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    In plain language

    This recall involves Medfusion 3500 and 4000 Syringe Pumps used in healthcare settings in Canada. They are being recalled because a software issue could lead to incorrect medication delivery (over or under-delivery). Healthcare professionals should stop using the affected products and follow the instructions from Smiths Medical.

    What to do

    • Stop using the product immediately.
    • Contact Smiths Medical for more information.
    • Follow all instructions provided by the manufacturer.

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    Affected products

    • Medfusion 3500 and 4000 Syringe Pumps

      Model: 4000-0105-51, 4000-0106-01, 67-2450-010600-01, 67-2450-010601-01

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Inappropriate medication delivery

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 4000-0105-51, 4000-0106-01, 67-2450-010600-01, 67-2450-010601-01

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    Inappropriate medication delivery

    What should consumers do?

    Stop using the product immediately. Contact Smiths Medical for more information. Follow all instructions provided by the manufacturer.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    Yes, there may be a health risk. Inappropriate medication delivery

    When was this product recalled?

    This product was recalled on September 1, 2020.

    Is the Medfusion brand affected by this recall?

    Yes, Medfusion products are affected by this recall. This recall involves Medfusion 3500 and 4000 Syringe Pumps used in healthcare settings in Canada. They are being recalled because a software issue could lead to incorrect medication delivery (over or under-delivery). Healthcare professionals should stop using the affected products and follow the instructions from Smiths Medical.