Class 2 Device Recall Peripherally inserted central catheter.

• Date Initiated by Firm: March 25, 2005
• Date Posted: December 15, 2005
• Recall Status: Terminated on August 08, 2011
• Recall Number: Z-0285-06
• Recall Event ID: 31670
• 510(K)Number: K920755
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
• Code Information: REF 384426
• Recalling Firm/ Manufacturer: Becton Dickinson Medical Systems; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: 801-565-2341
• Manufacturer Reason for Recall: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
• FDA Determined Cause: Other
• Action: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
• Quantity in Commerce: 5740 units
• Distribution: AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, 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.