Plasma Collection System 2 & PCS2 recall in Canada: labeling correction
In plain language
This recall involves the Plasma Collection System 2 and PCS2 medical devices in Canada. It's being recalled because of a correction needed in the device's user manual regarding anticoagulant volume calculation. The device itself is not defective. 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 if provided.
- Contact the manufacturer for more information regarding the labeling correction.
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Affected products
Plasma Collection System 2
Model: 06002-110-EXP-EW, 06002-CP-110
Lot: More than 10 numbers, contact manufacturer.
PCS2
Model: 06002-110-EXP-EW, 06002-110-NA, 06002-CP-110
Lot: More than 10 numbers, contact manufacturer.
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 06002-110-EXP-EW, 06002-110-NA, 06002-CP-110
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?
This recall involves the Plasma Collection System 2 and PCS2 medical devices in Canada. It's being recalled because of a correction needed in the device's user manual regarding anticoagulant volume calculation. The device itself is not defective. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Contact the manufacturer for more information regarding the labeling correction.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on May 22, 2020.