FDA Enforcement
Class II
Terminated
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. 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.
Recall: Z-2412-2012
·
Reported September 26, 2012
Enforcement
- Recall Number
- Z-2412-2012
- Event ID
- 63069
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 26, 2012
- Initiation Date
- September 4, 2012
- Classification Date
- September 20, 2012
- Termination Date
- September 3, 2013
- Address
- 100 Crossings Blvd, Warwick, RI, 02886-2850, United States
Description
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. 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
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 product
Code Info
Lot # HUWE1779
Distribution
Nationwide Distribution.
Quantity
49 units