Class 2 Device Recall Bard Access Marketing Brochures

• Date Initiated by Firm: July 20, 2015
• Date Posted: September 23, 2015
• Recall Status: Terminated on February 10, 2017
• Recall Number: Z-2808-2015
• Recall Event ID: 71757
• Product Classification: Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
• Product: Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
• Code Information: The brochures were purchased from the vendor on 04/14/2015, Code S120667R0
• Recalling Firm/ Manufacturer: Bard Access Systems; 605 N 5600 W; Salt Lake City UT 84116-3738
• For Additional Information Contact: Brenda Shelkey; 801-522-5974
• Manufacturer Reason for Recall: Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure.
• FDA Determined Cause: Labeling False and Misleading
• Action: Customer letter notification with reply form will be sent via Federal Express with delivery confirmation for US consignees on 7/20/15 informing them of the incorrect indication for use contained in the brochure.
• Quantity in Commerce: 1811
• Distribution: Distributed to domestic and foreign conference attendees.
• 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.