Spectra Optia Apheresis System recall in Canada: Air embolism risk
In plain language
This recall involves the Spectra Optia Apheresis System sold in Canada. It's being recalled because an alarm for air in the system may trigger without cause, potentially leading to an air embolism. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and serial numbers.
- Contact Terumo BCT Inc. for instructions.
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Affected products
Spectra Optia Apheresis System
Model: 61000
Lot: 1P02482, 1P06123, 1P06193
Why this matters
Air embolism 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: 1P02482, 1P06123, 1P06193
- 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 embolism risk
What should consumers do?
Stop using the product immediately. Check model and serial numbers. Contact Terumo BCT 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. Air embolism risk
When was this product recalled?
This product was recalled on August 7, 2019.
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 an alarm for air in the system may trigger without cause, potentially leading to an air embolism. Stop using the product and follow the return/repair steps in the official notice.