Class 2 Device Recall Bard PerFix Light Plug

• Date Initiated by Firm: October 08, 2014
• Date Posted: November 07, 2014
• Recall Status: Terminated 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/ Manufacturer: Davol, Inc., Subs. C. R. Bard, Inc.; 100 Crossings Blvd; Warwick RI 02886-2850
• For Additional Information Contact: 800-562-0027
• 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: 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