Reported Aug 2, 2023 · Ongoing
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Davol, Inc.
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: Davol, Inc. · 100 Crossings Blvd · Warwick, RI · 02886-2850
Is this the product you have?
- Ventralight ST 4" x 6"
- Ellipse with Echo PS Catalog Number5955460
- Lot codes and dates
- UDI-DI(01)00801741031724(17)240428(10)
- Lot Numbers
HUGS0481HUGS0549HUGS1019HUGS2031HUGS2079HUGT1627HUGS2025HUGT1989
- Amount recalled
- 1188 units US; 5 units OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
This product could cause temporary or reversible health problems — stop using it.
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