VAMP Optima, FloTrac sensor VAMP Optima system (2019-03-11)
In plain language
This recall involves the VAMP Optima and FloTrac sensor VAMP Optima systems sold in Canada. It's being recalled because unclear instructions for use could lead to diluted blood samples or blood clots. 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 VOPTIMAL, MHD8VLTW, and MHD8VRL5.
- Follow the return or repair instructions provided by Edwards Lifesciences LLC.
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Affected products
VAMP Optima
Model: VOPTIMAL
Lot: All lots
FloTrac Sensor VAMP Optima System
Model: MHD8VLTW, MHD8VRL5
Lot: All lots
Why this matters
Potential for diluted blood samples or blood clots
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: MHD8VLTW, MHD8VRL5, VOPTIMAL
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?
Potential for diluted blood samples or blood clots
What should consumers do?
Stop using the product immediately. Check model numbers VOPTIMAL, MHD8VLTW, and MHD8VRL5. Follow the return or repair instructions provided by Edwards Lifesciences LLC.
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. Potential for diluted blood samples or blood clots
When was this product recalled?
This product was recalled on April 5, 2019.
Is the VAMP Optima, FloTrac brand affected by this recall?
Yes, VAMP Optima, FloTrac products are affected by this recall. This recall involves the VAMP Optima and FloTrac sensor VAMP Optima systems sold in Canada. It's being recalled because unclear instructions for use could lead to diluted blood samples or blood clots. Stop using the product and follow the return/repair steps in the official notice.