Five S 5.3 recall in Canada: Sterility issue
In plain language
This recall involves the Five S 5.3 medical device sold in Canada. It's being recalled because there is no proof of sterility for the products. This could lead to patient infection if a contaminated product is used.
What to do
- Stop using the product immediately.
- Quarantine any remaining inventory.
- Return the reply form as instructed.
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Affected products
Five S 5.3
Model: 0915612-06
Lot: All lots.
Why this matters
Infection risk due to lack of sterility
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: 0915612-06
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?
Infection risk due to lack of sterility
What should consumers do?
Stop using the product immediately. Quarantine any remaining inventory. Return the reply form 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. Infection risk due to lack of sterility
When was this product recalled?
This product was recalled on August 16, 2023.
Is the Karl Storz Se & Co. Kg brand affected by this recall?
Yes, Karl Storz Se & Co. Kg products are affected by this recall. This recall involves the Five S 5.3 medical device sold in Canada. It's being recalled because there is no proof of sterility for the products. This could lead to patient infection if a contaminated product is used.