CUSTOM PACK WITH SOFTLINE recall in Canada: Sterility not maintained
In plain language
This recall involves CUSTOM PACK WITH SOFTLINE medical devices sold in Canada. It's being recalled because the sterile pouch may not maintain its sterility during storage and transport. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Return the product as instructed.
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Affected products
CUSTOM PACK WITH SOFTLINE
Model: BO-HQV 48412
Lot: 3000146594, 3000147939, 92299428
Why this matters
Sterility not maintained
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: 3000146594, 3000147939, 92299428
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: BO-HQV 48412
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?
Sterility not maintained
What should consumers do?
Stop using the product immediately. Check model and lot numbers. Return the product as instructed.
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. Sterility not maintained
When was this product recalled?
This product was recalled on April 1, 2021.