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U.S. Department of Health and Human Services

Class 2 Device Recall VENTRIO HERNIA PATCH

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  Class 2 Device Recall VENTRIO HERNIA PATCH see related information
Date Initiated by Firm April 08, 2010
Date Posted May 04, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = C.R. BARD, INC.
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