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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product 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.
Recall Number Z-2412-2012
Classification Class II
Code Info Lot # HUWE1779
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 product

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.