Medical device recall in Canada: Presource Kits may cause organ injury
In plain language
This recall involves LAPRAOSCOPIE and ENDOCHOLECYSTECTOMIE Presource Kits containing Hydroline and Pulse Wave Trumpet Valves sold in Canada. They are being recalled because a component may not close properly, which could cause continuous suction during a procedure. This could lead to reduced visibility and potential injury to organs and body tissue. 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.
- Contact Cardinal Health for return instructions.
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Affected products
LAPRAOSCOPIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves
Model: SLC30LAJTA
Lot: 788534, 832528
ENDOCHOLECYSTECTOMIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves
Model: SLC30ECBEB
Lot: 795674, 804705
Why this matters
Potential injury to organs and body tissue
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: 788534, 832528, 795674, 804705
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: SLC30ECBEB, SLC30LAJTA
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?
Potential injury to organs and body tissue
What should consumers do?
Stop using the product immediately. Check model and lot numbers. Contact Cardinal Health for return 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. Potential injury to organs and body tissue
When was this product recalled?
This product was recalled on July 13, 2018.