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.
FDA Recall Z-2413-2012 · Posted 2012-09-20
Recalling FirmDavol, Inc., Subs. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeFTL
Date Initiated2012-09-04
Date Terminated2013-09-03
Product Quantity49 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
Firm Action
Davol issued an "URGENT: MEDICAL DEVICE RECALL" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter advises customers to examine their inventory and quarantine affected product for return to the firm. Customers were asked to complete and return a Recall Effectiveness Check Form. Contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027 if you have any questions.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.