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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Soft Mesh patch

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  Class 2 Device Recall Bard Soft Mesh patch see related information
Date Initiated by Firm April 25, 2011
Date Posted May 23, 2011
Recall Status1 Terminated 3 on October 28, 2011
Recall Number Z-2239-2011
Recall Event ID 58685
510(K)Number K033814  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Bard¿ Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010.

The Bard¿ Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric".
Code Information Lot# HUUF0530 
Recalling Firm/
Manufacturer		 Davol, Inc., Sub. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact Paul Robinson
401-825-8697
Manufacturer Reason
for Recall		 Mislabeling: complaints of product labeled as Bard¿ Soft Mesh 4" x 6" containing Bard¿ Soft Mesh 6" x 6"
FDA Determined
Cause 2		 Labeling mix-ups
Action Davol issued an URGENT: MEDICAL DEVICE RECALL notification letter to customers dated April 25, 2011, informing them the recall involving a single lot of the BARD Soft Mesh - Lot# HUUF0530. This recall has been initiated because this lot number may contain a different size patch than is indicated. Customers were instructed to immediately examine inventory and quarantine product subject to recall. Customers are asked to identify and notify their customers to whom recalled product may have been further distributed. A Recall Effectiveness Check reply form should be completed and returned to Davol via fax (401-825-8753). For directions on returning product or for questions regarding the recall, contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027.
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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