Reported Oct 6, 2021 · Terminated
The Instructions for Use (IFU) for
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) for
5 of 5 products
| Model / number | Product as published |
|---|---|
631408 | sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm |
631608 | sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm |
631809 | sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm |
632010 | sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm |
632211 | sterile |
- 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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