NxStage System One - Cycler recall in Canada: risk of serious injury
In plain language
This recall involves the NxStage System One - Cycler (Chronic Application) sold in Canada. It's being recalled because it may remove too much or too little fluid during dialysis, which could lead to serious injury. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers: NX1000-1, NX1000-3, NX1000-3-A, NX1000-3-CAN.
- Follow the instructions provided by your healthcare professional or the manufacturer.
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Affected products
NxStage System One - Cycler (Chronic Application)
Model: NX1000-1, NX1000-3, NX1000-3-A, NX1000-3-CAN
Lot: All lots
Why this matters
Risk of serious injury due to fluid imbalance during dialysis
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: NX1000-1, NX1000-3, NX1000-3-A, NX1000-3-CAN
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.
Frequently Asked Questions
Why was this product recalled?
Risk of serious injury due to fluid imbalance during dialysis
What should consumers do?
Stop using the product immediately. Check model numbers: NX1000-1, NX1000-3, NX1000-3-A, NX1000-3-CAN. Follow the instructions provided by your healthcare professional or the manufacturer.
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 serious injury due to fluid imbalance during dialysis
When was this product recalled?
This product was recalled on November 1, 2019.
Is the NxStage System One brand affected by this recall?
Yes, NxStage System One products are affected by this recall. This recall involves the NxStage System One - Cycler (Chronic Application) sold in Canada. It's being recalled because it may remove too much or too little fluid during dialysis, which could lead to serious injury. Stop using the product and follow the return/repair steps in the official notice.