Cook's Inc. catheter and stent sets recall in Canada: Injury risk
In plain language
This recall involves various catheter and stent sets from Cook's Inc. sold in Canada. They are being recalled because a wire guide may be incorrectly loaded, potentially introducing the stiff tip into a patient. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot or serial numbers if provided.
- Contact Cook's Inc. for return instructions.
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Affected products
Urethral Dilator Set
Model: 073701
Lot: 8404945
Angled Tip Ureteral Catheter Set
Model: 023105
Lot: 8409525
Bentson PTFE Wire Guide
Model: 635413, 638453, 638497
Lot: 7760235, 7875295, 7881599, 8062433, 8065992, 8287799, 8290383, 8290384, 8404559, 8404562, 8548813
C-Flex Double Pigtail Ureteral Stent Set
Model: 036510, 036516
Lot: NS7953136, NS8180860
Sof-Flex Double Pigtail Ureteral Stent Set
Model: 039512, 039516, 039610
Lot: 8070691, 8183342, 8183343, 8070693, 8172134, 8187189, 8424304, 7990842, 7990841
Sof-Flex Multi-Length Ureteral Stent Set
Model: 039XXX
Lot: NS8037667, 8599605
Urethral Dilation Balloon Catheter with Open Tip
Model: UDBS-070029-OW
Lot: 8683459
Universa Soft Ureteral Stent Set
Model: US-XX, USH-XXX
Lot: More than 10 numbers, contact manufacturer.
Universa Firm Ureteral Stent Set
Model: UFH-XXX
Lot: 8070702, 8594594, NS8197934, NS8417599, NS8417600
Why this matters
Injury risk from incorrectly loaded wire guide
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: 7760235, 7875295, 7881599, 8062433, 8065992, 8287799, 8290383, 8290384, 8404559, 8404562, 8548813, 8070691, 8183342, 8183343, 8070693, 8172134, 8187189, 8424304, 7990842, 7990841, 8070702, 8594594, NS8197934, NS8417599, NS8417600, 8404945, 8409525, 8683459, More than 10 numbers, contact manufacturer., NS7953136, NS8180860, NS8037667, 8599605
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 023105, 036510, 036516, 039512, 039516, 039610, 039XXX, 073701, 635413, 638453, 638497, UDBS-070029-OW, UFH-XXX, US-XX, USH-XXX
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?
Injury risk from incorrectly loaded wire guide
What should consumers do?
Stop using the product immediately. Check the lot or serial numbers if provided. Contact Cook's Inc. 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. Injury risk from incorrectly loaded wire guide
When was this product recalled?
This product was recalled on January 23, 2019.
Is the Cook's Inc. brand affected by this recall?
Yes, Cook's Inc. products are affected by this recall. This recall involves various catheter and stent sets from Cook's Inc. sold in Canada. They are being recalled because a wire guide may be incorrectly loaded, potentially introducing the stiff tip into a patient. Stop using the product and follow the return steps in the official notice.