RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026SPIROSOfficial source

    SPIROS CLOSED MALE LUER recall in Canada: Leaking hazard

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    In plain language

    This recall involves certain lots of SPIROS CLOSED MALE LUER medical devices sold in Canada. They are being recalled because they may leak due to a molding defect. Stop using the product and follow the return steps in the official notice.

    What to do

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

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    Affected products

    • CLAVE EXT. SET

      Model: CH3011, CH3762

      Lot: 5125297, 5135759

    • SPIROS CLOSED MALE LUER

      Model: 20120-01

      Lot: 5141416

    • SPINNING SPIROS CLOSED MALE LUER

      Model: 20130-01, K7040-001

      Lot: 5125300, 5135765, 5142935

    Why this matters

    Leaking hazard

    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: 5125297, 5135759, 5125300, 5135765, 5142935, 5141416

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 20120-01, 20130-01, CH3011, CH3762, K7040-001

    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?

    Leaking hazard

    What should consumers do?

    Stop using the product immediately. Check the lot or model numbers provided. Contact ICU Medical Inc. 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. Leaking hazard

    When was this product recalled?

    This product was recalled on October 1, 2021.

    Is the SPIROS brand affected by this recall?

    Yes, SPIROS products are affected by this recall. This recall involves certain lots of SPIROS CLOSED MALE LUER medical devices sold in Canada. They are being recalled because they may leak due to a molding defect. Stop using the product and follow the return steps in the official notice.