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U.S. Department of Health and Human Services

Class 2 Device Recall Bard PerFix Light Plug

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  Class 2 Device Recall Bard PerFix Light Plug see related information
Date Initiated by Firm October 08, 2014
Date Posted November 07, 2014
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-0191-2015
Recall Event ID 69464
510(K)Number K092032  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Bard¿ PerFix Light Plug

The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
Code Information Lot# HUYD0176
Recalling Firm/
Davol, Inc., Subs. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact
Manufacturer Reason
for Recall
The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.
FDA Determined
Cause 2
Error in labeling
Action Davol Inc. (Subsidiary of C.R. Bard, Inc)sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this communication. A sample of the product labeling for the lot has been enclosed to assist in product code and lot number identification. The enclosure also depicts the supplied label as well as an image of the label with the correct information. If you have any remaining inventory, a copy of this communication can be kept with the units for future medical record documentation purposes. If you have already used some of the product lot, you may amend any patient record(s) based upon the content of this communication. Please complete and return the accompanying Effectiveness Check Form attached to this letter regardless of whether or not you have any remaining units of the affected product lot. If you may have further distributed or transferred this product, please identify the respective organizations and notify them of this product communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This product communication is being made with the knowledge of the Food and Drug Administration. We apologize for any inconvenience this may have caused your organization. Please contact the Davol Customer Service Department at 1-800-556-6275 or C.R. Bard Medical Services & Support Department at 1-800-562-0027 if you have any questions.
Quantity in Commerce 78 units
Distribution US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
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.