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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Ventralight ST Mesh

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  Class 2 Device Recall Bard Ventralight ST Mesh see related information
Date Initiated by Firm September 04, 2012
Date Posted September 20, 2012
Recall Status1 Terminated 3 on September 03, 2013
Recall Number Z-2413-2012
Recall Event ID 63069
510(K)Number K101851  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product 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.
Code Information Lot # HUWE1780
Recalling Firm/
Manufacturer
Davol, Inc., Subs. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact Jeff DeSanty
401-825-8633
Manufacturer 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
FDA Determined
Cause 2
Mixed-up of materials/components
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.
Quantity in Commerce 49 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 = DAVOL INC., SUB. C.R. BARD, INC.
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