Class 2 Device Recall VENTRIO HERNIA PATCH

• Date Initiated by Firm: April 08, 2010
• Date Posted: May 04, 2010
• Recall Status: Terminated on October 27, 2011
• Recall Number: Z-1536-2010
• Recall Event ID: 55251
• 510(K)Number: K081777
• Product Classification: mesh, surgical, polymeric - Product Code FTL
• Product: Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
• Code Information: REF 0010211 Lot DATB0015
• Recalling Firm/ Manufacturer: Davol, Inc., Sub. C. R. Bard, Inc.; 100 Crossings Blvd; Warwick RI 02886-2850
• For Additional Information Contact: 401-825-8633
• Manufacturer Reason for Recall: Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")
• FDA Determined Cause: Labeling mix-ups
• Action: An "URGENT RECALL: BARD VENTRIO SMALL OVAL HERNIA PATCH (LOT DATB0015" letter dated April 8, 2010, was issued by the firm (Davol) to all customers via FedEx overnight with signature required. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to: please examine their inventory and immediately discontinue use of this lot; contact the Davol Customer Service Department at 1-800-556-6275 for instructions on how to return product to firm; complete and fax the EFFECTIVENESS CHECK sheet to 1-401-825-8753, and forward a copy of this letter, if they are a distributor, to their customers who have received the product and lot number. All products returned will be held at the Davol, Warwick location. Please contact your Davol Territory Manager or C.R. Bard's Medical Service Support Department at 1-800-562-0027 if you have any other questions.
• Quantity in Commerce: 198 units
• Distribution: Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FTL