Cellex Photopheresis System recall in Canada: Thromboembolic events
In plain language
This recall involves the Cellex Photopheresis System used in Canada. It's being recalled because of reports of thromboembolic events associated with its use in patients with Graft versus Host Disease (GvHD). The device's Operator's Manual will be updated with a new caution statement.
What to do
- Consult with your healthcare provider regarding this medical device.
- Follow any instructions from your healthcare provider or hospital.
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Affected products
Cellex Photopheresis System
Model: CELLEX
Why this matters
Thromboembolic events
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 model number
Model numbers are typically on the product label or packaging.
Affected models: CELLEX
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?
Thromboembolic events
What should consumers do?
Consult with your healthcare provider regarding this medical device. Follow any instructions from your healthcare provider or hospital.
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. Thromboembolic events
When was this product recalled?
This product was recalled on September 7, 2018.
Is the THERAKOS CELLEX brand affected by this recall?
Yes, THERAKOS CELLEX products are affected by this recall. This recall involves the Cellex Photopheresis System used in Canada. It's being recalled because of reports of thromboembolic events associated with its use in patients with Graft versus Host Disease (GvHD). The device's Operator's Manual will be updated with a new caution statement.