Introducer Sheath recall in Canada: manufacturing defect
In plain language
This recall involves certain Introducer Sheath products sold in Canada. They are being recalled due to a manufacturing defect that may prevent a part of the sheath from peeling apart correctly. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the model and lot numbers provided.
- Contact Merit Medical Systems Inc. for instructions.
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Affected products
H.Lee Safesheath CSG (Coronary Sinus Guide) Hemostatic Introducer System
Model: WOR-CSG-B1-09, WOR-CSG-B2-09, WOR-CSG-BL1-09
Lot: I1825799, I1825806, I1838620, I1845505
Preclude SNAP Spittable Sheath Introducer
Model: PLS-2507
Lot: I1866067
Worley Advanced LVI Lateral Vein Introducer Kit
Model: WORLVI-75-5-62-55-RE
Lot: I1825782
Why this matters
Manufacturing 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: I1825782, I1825799, I1825806, I1838620, I1845505, I1866067
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: PLS-2507, WOR-CSG-B1-09, WOR-CSG-B2-09, WOR-CSG-BL1-09, WORLVI-75-5-62-55-RE
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?
Manufacturing defect
What should consumers do?
Stop using the product immediately. Check the model and lot numbers provided. Contact Merit Medical Systems Inc. for 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. Manufacturing defect
When was this product recalled?
This product was recalled on October 2, 2020.