Spectra Optia Apheresis System recall in Canada: Air infusion risk
In plain language
This recall involves the Spectra Optia Apheresis System sold in Canada. It's being recalled because if a blood warmer is added after a procedure starts, the system may not prompt the user to prime it, which could lead to air being infused into a patient or donor. 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.
- Return, repair, or dispose of it as instructed.
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Affected products
Spectra Optia Apheresis System
Model: 61000
Lot: All lots
Why this matters
Air infusion risk
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: 61000
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?
Air infusion risk
What should consumers do?
Stop using the product immediately. Check model numbers. Return, repair, 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. Air infusion risk
When was this product recalled?
This product was recalled on April 24, 2018.
Is the Spectra Optia brand affected by this recall?
Yes, Spectra Optia products are affected by this recall. This recall involves the Spectra Optia Apheresis System sold in Canada. It's being recalled because if a blood warmer is added after a procedure starts, the system may not prompt the user to prime it, which could lead to air being infused into a patient or donor. Stop using the product and follow the return/repair steps in the official notice.