Z-2413-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- September 4, 2012
- Termination Date
- September 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
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.
Reason for Recall
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
Distribution Pattern
Nationwide Distribution.
Code Information
Lot # HUWE1780