RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026SIGMA SPECTRUMOfficial source

    SIGMA SPECTRUM Infusion System recall in Canada: reduced flow accuracy

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    In plain language

    This recall involves the SIGMA SPECTRUM Infusion System (V8 Platform) sold in Canada. It's being recalled because using multiple extension sets can reduce flow accuracy. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Contact Baxter Healthcare Corporation for more information.

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    Affected products

    • SIGMA SPECTRUM Infusion System (V8 Platform)

      Model: 35700BAX2

      Lot: All serial numbers

    Why this matters

    Reduced flow accuracy

    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: All serial numbers

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 35700BAX2

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Reduced flow accuracy

    What should consumers do?

    Stop using the product immediately. Contact Baxter Healthcare Corporation for more information.

    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. Reduced flow accuracy

    When was this product recalled?

    This product was recalled on April 1, 2021.

    Is the SIGMA SPECTRUM brand affected by this recall?

    Yes, SIGMA SPECTRUM products are affected by this recall. This recall involves the SIGMA SPECTRUM Infusion System (V8 Platform) sold in Canada. It's being recalled because using multiple extension sets can reduce flow accuracy. Stop using the product and follow the return/repair steps in the official notice.