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U.S. Department of Health and Human Services

Class 2 Device Recall BARD Mesh Preshaped

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  Class 2 Device Recall BARD Mesh Preshaped see related information
Date Initiated by Firm October 15, 2010
Date Posted November 23, 2010
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-0446-2011
Recall Event ID 57008
510(K)Number K052155  
Product Classification mesh, surgical, polymeric - Product Code FTL
Product BARD¿ Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm)
Product code: 0112700

Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects
Code Information Lot : HUUF0412.
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: The labeled BARD¿ Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD¿ Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
FDA Determined
Cause 2		 Process control
Action Davol issued an "URGENT MEDICAL DEVICE RECALL" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please 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 144 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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