Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series (2018-06-22)
In plain language
This recall involves Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series sold in Canada. It's being recalled because the sterilization symbols on the labels are conflicting. The labels indicate two different sterilization methods, but only one is correct. 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: IN1608-SO, IN1610-SO, IN1612-SO, IN1614-SO, IN2008-SO, IN2010-SO, IN2012-SO, IN2014-SO.
- Contact the manufacturer for lot or serial numbers.
- Follow the return or disposal instructions from the manufacturer.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series
Model: IN1608-SO, IN1610-SO, IN1612-SO, IN1614-SO, IN2008-SO, IN2010-SO, IN2012-SO, IN2014-SO
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: IN1608-SO, IN1610-SO, IN1612-SO, IN1614-SO, IN2008-SO, IN2010-SO, IN2012-SO, IN2014-SO
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 Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series sold in Canada. It's being recalled because the sterilization symbols on the labels are conflicting. The labels indicate two different sterilization methods, but only one is correct. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers: IN1608-SO, IN1610-SO, IN1612-SO, IN1614-SO, IN2008-SO, IN2010-SO, IN2012-SO, IN2014-SO. Contact the manufacturer for lot or serial numbers. Follow the return or disposal instructions from the manufacturer.
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 July 5, 2018.
Is the Blom-Singer brand affected by this recall?
Yes, Blom-Singer products are affected by this recall. This recall involves Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series sold in Canada. It's being recalled because the sterilization symbols on the labels are conflicting. The labels indicate two different sterilization methods, but only one is correct. Stop using the product and follow the return/repair steps in the official notice.