Pneumostat Chest Drain Valve recall in Canada: patient risk
In plain language
This recall involves the Atrium Pneumostat Chest Drain Valve sold in Canada. It's being recalled because the instructions for use did not provide enough warnings for use in preterm infants, which led to patient harm. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Atrium/Getinge for more information.
- Follow the instructions provided by your healthcare professional.
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Affected products
PNEUMOSTAT CHEST DRAIN VALVE
Model: 16100
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Unreasonable patient risk and harm
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: 16100
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?
Unreasonable patient risk and harm
What should consumers do?
Stop using the product immediately. Contact Atrium/Getinge for more information. Follow the instructions provided by your healthcare professional.
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. Unreasonable patient risk and harm
When was this product recalled?
This product was recalled on September 24, 2021.
Is the Atrium brand affected by this recall?
Yes, Atrium products are affected by this recall. This recall involves the Atrium Pneumostat Chest Drain Valve sold in Canada. It's being recalled because the instructions for use did not provide enough warnings for use in preterm infants, which led to patient harm. Stop using the product and follow the return steps in the official notice.