Class 2 Device Recall Introducer catheter

• Date Initiated by Firm: February 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 10, 2004
• Recall Number: Z-0587-04
• Recall Event ID: 28397
• 510(K)Number: K974764
• Product Classification: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
• Product: BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
• Code Information: Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy; 9450 South State Street; Sandy UT 84070
• For Additional Information Contact: 801-565-2341
• Manufacturer Reason for Recall: Splittable catheter introducer may not fully split or may separate non-uniformly.
• FDA Determined Cause: Other
• Action: On 02/03/2004, all consignees were notified by telephone and letter.
• Quantity in Commerce: 12000 units
• Distribution: Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
• 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