Class 2 Device Recall Intravascular catheter

• Date Initiated by Firm: March 09, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 24, 2011
• Recall Number: Z-0783-04
• Recall Event ID: 28566
• 510(K)Number: K920755
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: BD L-Cath NN (24ga x 30cm), L-Cath Catheter System
• Code Information: REF 384522, Lot numbers 2226035, 3274339, 3240808, 3294199, 3365138, 3220423, 3192307, 3073801. Added on 6/10/2004:-- 2252516, 2268877.
• 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: Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
• FDA Determined Cause: Other
• Action: All consignees were notified by telephone on 03/09/2004, followed by a fax letter.
• Quantity in Commerce: 5690 units
• Distribution: Nationwide. Foreign distribution to Australia, Canada and Japan.
• 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 and Original Applicant = LUTHER MEDICAL PRODUCTS, INC.