Auto Suture Trocar recall in Canada: performance issues
In plain language
This recall involves Auto Suture Blunt Tip and Structural Balloon Trocars sold in Canada. They are being recalled due to performance issues where the trocar seal may disengage. This recall is for healthcare professionals. Contact the manufacturer for more information.
What to do
- Stop using the product if it is not in accordance with the mesh instructions for use (IFU).
- Contact the manufacturer for additional information.
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Affected products
Auto Suture Blunt Tip Trocar
Model: OMS-T10BT, OMS-T10BTNL, OMS-T10BTS, OMS-T10BTSNL, OMS-T12BT, OMS-T12BTNL
Lot: More than 10 numbers, contact manufacturer.
Auto Suture Structural Balloon Trocar
Model: OMS-T10SB
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: OMS-T10BT, OMS-T10BTNL, OMS-T10BTS, OMS-T10BTSNL, OMS-T10SB, OMS-T12BT, OMS-T12BTNL
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 Auto Suture Blunt Tip and Structural Balloon Trocars sold in Canada. They are being recalled due to performance issues where the trocar seal may disengage. This recall is for healthcare professionals. Contact the manufacturer for more information.
What should consumers do?
Stop using the product if it is not in accordance with the mesh instructions for use (IFU). Contact the manufacturer for 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?
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 March 13, 2024.
Is the COVIDIEN LLC brand affected by this recall?
Yes, COVIDIEN LLC products are affected by this recall. This recall involves Auto Suture Blunt Tip and Structural Balloon Trocars sold in Canada. They are being recalled due to performance issues where the trocar seal may disengage. This recall is for healthcare professionals. Contact the manufacturer for more information.