RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026CME AmericaOfficial source

    CME America BodyGuard Infusion Administration Sets (2020-06-16)

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    In plain language

    This recall involves CME America BodyGuard Infusion Administration Sets sold in Canada. They are being recalled because they may not deliver medication accurately, which could cause over-infusion or under-infusion. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model numbers if provided.
    • Return or dispose of it as instructed.

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    Affected products

    • BodyGuard Infusion Administration Sets

      Model: A100-163XES, A120-003XS2YV, A120-003XSNY, A120-112XSFK, A120-160SAS, A120-160XSFK

      Lot: All lots

    Why this matters

    Over-infusion or under-infusion risk

    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 lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: A100-163XES, A120-003XS2YV, A120-003XSNY, A120-112XSFK, A120-160SAS, A120-160XSFK

    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?

    Over-infusion or under-infusion risk

    What should consumers do?

    Stop using the product immediately. Check model numbers if provided. Return or dispose of it as instructed.

    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. Over-infusion or under-infusion risk

    When was this product recalled?

    This product was recalled on October 9, 2020.

    Is the CME America brand affected by this recall?

    Yes, CME America products are affected by this recall. This recall involves CME America BodyGuard Infusion Administration Sets sold in Canada. They are being recalled because they may not deliver medication accurately, which could cause over-infusion or under-infusion. Stop using the product and follow the return steps in the official notice.