Class 3 Device Recall PICC catheters

• Date Initiated by Firm: December 20, 2005
• Date Posted: March 16, 2006
• Recall Status: Terminated on August 11, 2009
• Recall Number: Z-0542-06
• Recall Event ID: 34518
• 510(K)Number: K023374 K034020
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: Groshong NXT ClearVue 4 Fr. Single-Lumen PICC, Bard Access Systems, Inc.
• Code Information: Product Code 7617408, Lot #REPI0738
• Recalling Firm/ Manufacturer: Bard Access Systems, Inc; 5425 Amelia Earhart Dr; Salt Lake City UT 84116-3713
• For Additional Information Contact: 801-595-0700
• Manufacturer Reason for Recall: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 12/20/2005.
• Quantity in Commerce: 450
• Distribution: Nationwide, including VA facilities in CA, FL and IL. No foreign or military 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 = LJS