Device product
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Z-2413-2012
Product summary
- Event
- Event 63069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-2413-2012
Official wording
Reason: Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
Code information: Lot # HUWE1780
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Labeling or packaging
Mislabeled