Medical device recall in Canada: PROXIMATE staplers may have assembly defect
In plain language
This recall involves PROXIMATE HCS Hemorrhoidal Circular Stapler and PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set sold in Canada. They are being recalled because some devices may have been assembled without a washer. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Ethicon for return instructions.
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Affected products
PROXIMATE HCS Hemorrhoidal Circular Stapler
Model: PPH 01
Lot: P9461W, P94K20
PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set
Model: PPH03
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Assembly defect
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., P9461W, P94K20
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: PPH 01, PPH03
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?
Assembly defect
What should consumers do?
Stop using the product immediately. Contact Ethicon 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. Assembly defect
When was this product recalled?
This product was recalled on January 9, 2019.
Is the PROXIMATE brand affected by this recall?
Yes, PROXIMATE products are affected by this recall. This recall involves PROXIMATE HCS Hemorrhoidal Circular Stapler and PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set sold in Canada. They are being recalled because some devices may have been assembled without a washer. Stop using the product and follow the return steps in the official notice.