Reported Jul 8, 2015 · Terminated
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair,…
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
Is this the product you have?
- Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
- Lot codes and dates
Product Code 433008Batch 301509/02Serial Numbers 000151520400015152050001515206000151520700015152080001515209000151521000015152110001515212000151521300015152140001515215
- Amount recalled
- 12
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
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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