RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026BaxterOfficial source

    Baxter Reconstitution Device recall in Canada: sterilization risk

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    In plain language

    This recall involves Baxter Reconstitution Devices and PD Empty Bag Systems sold in Canada. They are being recalled because they may not have been properly sterilized. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model and lot numbers.
    • Contact Baxter Corporation for return instructions.

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    Affected products

    • RECONSTITUTION DEVICE

      Model: NGB8064M

      Lot: 16G22V239, 16H01V523, 17H03V526, 18G02V160, 18G05V161

    • PD 3L EMPTY BAG SYSTEM

      Model: XMC4284

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Risk of infection due to improper sterilization

    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: 16G22V239, 16H01V523, 17H03V526, 18G02V160, 18G05V161, More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: NGB8064M, XMC4284

    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?

    Risk of infection due to improper sterilization

    What should consumers do?

    Stop using the product immediately. Check model and lot numbers. Contact Baxter Corporation for return instructions.

    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. Risk of infection due to improper sterilization

    When was this product recalled?

    This product was recalled on June 30, 2021.

    Is the Baxter brand affected by this recall?

    Yes, Baxter products are affected by this recall. This recall involves Baxter Reconstitution Devices and PD Empty Bag Systems sold in Canada. They are being recalled because they may not have been properly sterilized. Stop using the product and follow the return steps in the official notice.