medical Class II Updated 2023-08-02

Davol, Inc. recalls Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number:

Recalled Product

Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989
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