Tracoe Experc Percut Dilation Sets recall in Canada: performance issue
In plain language
This recall involves Tracoe Experc Percut Dilation Sets sold in Canada. They are being recalled because of a performance issue where the silicone sleeve may tear during removal. Healthcare professionals should contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer if you require additional information.
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Affected products
Tracoe Experc Percut Dila Tracheo Set W/Trach/Atrau Insert Spiral Reinforce
Model: 420-08, 420-09, 450-08-P, 450-09-P
Lot: Not applicable.
Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Extra-Long
Model: 421-08, 421-09, 451-08-P, 451-09-P
Lot: Not applicable.
Tracoe Experc Percut Dilation Tracheostomy Set W/Trach/Atraumatic Inserter
Model: 311-08-P, 311-09-P, 330-08, 330-09, 423-08, 423-09, 424-08, 424-09, 460-08-P, 460-09-P, 461-08-P, 461-09-P
Lot: Not applicable.
Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Fenestrate
Model: 312-08-P, 312-09-P, 331-08, 331-09
Lot: Not applicable.
Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Suct Line
Model: 316-08-P, 316-09-P, 332-08, 332-09, 888-316-08-P, 888-316-09-P, 888-332-08, 888-332-09
Lot: Not applicable.
Tracoe Experc Percut Dila Tracheo Set W/Trach/Atrau Inserter Sys Suct Line
Model: 422-08, 422-09, 425-08, 425-09, 470-08-P, 470-09-P, 471-08-P, 471-09-P
Lot: Not applicable.
Why this matters
Performance issue
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: Not applicable.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 311-08-P, 311-09-P, 312-08-P, 312-09-P, 316-08-P, 316-09-P, 330-08, 330-09, 331-08, 331-09, 332-08, 332-09, 420-08, 420-09, 421-08, 421-09, 422-08, 422-09, 423-08, 423-09, 424-08, 424-09, 425-08, 425-09, 450-08-P, 450-09-P, 451-08-P, 451-09-P, 460-08-P, 460-09-P, 461-08-P, 461-09-P, 470-08-P, 470-09-P, 471-08-P, 471-09-P, 888-316-08-P, 888-316-09-P, 888-332-08, 888-332-09
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?
Performance issue
What should consumers do?
Stop using the product immediately. Contact the manufacturer if you require additional information.
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. Performance issue
When was this product recalled?
This product was recalled on December 1, 2022.
Is the Tracoe Medical GmbH brand affected by this recall?
Yes, Tracoe Medical GmbH products are affected by this recall. This recall involves Tracoe Experc Percut Dilation Sets sold in Canada. They are being recalled because of a performance issue where the silicone sleeve may tear during removal. Healthcare professionals should contact the manufacturer for more information.