Temporary Bipolar Pacing Leads recall in Canada: connectivity issues
In plain language
This recall involves Temporary Bipolar Pacing Leads sold in Canada. They are being recalled because the connector cap may expose the wire, leading to loss of connectivity or breakage. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers: TB 4 F U, TB 5 F U, TB 6 F U.
- Contact your healthcare provider for instructions.
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Affected products
Temporary Bipolar Pacing Leads
Model: TB 4 F U, TB 5 F U, TB 6 F U
Lot: All lots
Why this matters
Loss of connectivity or breakage of wires
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: TB 4 F U, TB 5 F U, TB 6 F U
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?
Loss of connectivity or breakage of wires
What should consumers do?
Stop using the product immediately. Check model numbers: TB 4 F U, TB 5 F U, TB 6 F U. Contact your healthcare provider for instructions.
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. Loss of connectivity or breakage of wires
When was this product recalled?
This product was recalled on October 26, 2018.