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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Ventrio

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  Class 2 Device Recall Bard Ventrio see related information
Date Initiated by Firm October 15, 2010
Date Posted November 19, 2010
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-0423-2011
Recall Event ID 57010
510(K)Number K081777  
Product Classification Polymeric Surgical Mesh - Product Code FTL
Product BARD¿ Ventrio¿ Large Oval Hernia Patch 5.4" x 7.0"
Product Code: 0010212

Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
Code Information Lot Number: HUUG1825
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: Hernia Patch may be a different size than on the product label
FDA Determined
Cause 2		 Packaging process control
Action Davol notified accounts by an Urgent: Medical Device Recall letter on 10/15/10 via overnight delivery. The letter stated that the product maybe a different size than indicated on the product label. It also identified the affected product. Accounts are requested to examine their inventory, remove, and return recalled product. Customers are to notify any of their customers that they may have further distributed the affected product to by including a copy of the recall notice. Customers should contact Davol Customer Service 1-800-556-6275 for instructions on how to return the affected product. Customers are also requested to complete and fax back the attached fax sheet to 1-401-825-8753. If there are any additional questions, customers should contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Service Support Department at 1-800-562-0027.
Quantity in Commerce 184 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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