RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    ChemoClave and ChemoLock Vial Spikes recall in Canada: plastic particulate risk

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    In plain language

    This recall involves ChemoClave and ChemoLock Vial Spikes sold in Canada. They are being recalled because they may contain plastic burr particulate. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the model and lot numbers.
    • Contact ICU Medical Inc. for instructions.

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    Affected products

    • ChemoClave Vial Spike

      Model: CH-80S

      Lot: 3839690, 3873006

    • ChemoLock Vial Spike

      Model: CL-80S, CL-80S-10, CL-80S-5

      Lot: 3853997, 3853999, 3854004, 3854005, 3866764, 3866769, 3866770, 3872085, 3932908

    Why this matters

    Risk of plastic particulate

    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: 3839690, 3873006, 3853997, 3853999, 3854004, 3854005, 3866764, 3866769, 3866770, 3872085, 3932908

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: CH-80S, CL-80S, CL-80S-10, CL-80S-5

    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 plastic particulate

    What should consumers do?

    Stop using the product immediately. Check the model and lot numbers. Contact ICU Medical Inc. for 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 plastic particulate

    When was this product recalled?

    This product was recalled on March 18, 2019.