Class 2 Device Recall Intravascular Catheter

• Date Initiated by Firm: February 03, 2005
• Date Posted: March 10, 2005
• Recall Status: Terminated on May 17, 2005
• Recall Number: Z-0584-05
• Recall Event ID: 31214
• 510(K)Number: K032843
• Product Classification: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
• Product: BD Nexiva Closed IV Catheter System, 18 gauge
• Code Information: Catalog Numbers: 383508, 383509 Lot Numbers: All lot numbers.
• FEI Number: 1710034
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy; 9450 S State St; Sandy UT 84070
• For Additional Information Contact: Alicia Mares; 801-673-3340
• Manufacturer Reason for Recall: The Y-luer connection may crack during normal product use.
• FDA Determined Cause: Other
• Action: Customers were contacted by phone on 02/03/2005, and letters dated 02/10/05 were sent.
• Quantity in Commerce: 1500 catheters
• Distribution: Domestic distribution: IL, UT, TX, FL. No foreign distribution. No distribution to military or VA facilities.
• 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 = FOZ