Enforcement Report - Week of September 26, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-2413-2012 |
| Classification | Class II |
| Code Info | Lot # HUWE1780 |
| Product Distributed Qty | 49 units |
| 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 |
Event Detail
| Event Id | 63069 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Davol, Inc., Subs. C. R. Bard, Inc. |
| City | Warwick |
| State | RI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
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