Class 3 Device Recall 3F Procedure Kit

• Date Initiated by Firm: April 04, 2003
• Date Posted: May 15, 2003
• Recall Status: Terminated on July 30, 2003
• Recall Number: Z-0832-03
• Recall Event ID: 26054
• 510(K)Number: K945499
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: BD First PICC 3F 65 cm Single Lumen Procedure Kit.
• Code Information: Reference No. 384134, Lot No. 2326770.
• FEI Number: 1710034
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy; 9450 South State Street; Sandy UT 84070
• For Additional Information Contact: Ms. Rachel LeBlanc; 801-565-2649
• Manufacturer Reason for Recall: A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
• FDA Determined Cause: Other
• Action: All distributors and known hospitals were notified on 04/04/2003 by telephone, followed by a fax notification.
• Quantity in Commerce: 840 kits
• Distribution: Nationwide
• 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