Reported Oct 6, 2021 · Terminated
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch…
Vascutek, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vascutek, Ltd. · Newmains Avenue · Inchinnan, N/A · N/A
Is this the product you have?
- The Instructions for Use (IFU) forCarotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
- Lot codes and dates
- To be reported.
- Amount recalled
- 159 total vascular grafts and patches
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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