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U.S. Department of Health and Human Services

Class 2 Device Recall Intravascular catheter

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  Class 2 Device Recall Intravascular catheter see related information
Date Initiated by Firm March 09, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 24, 2011
Recall Number Z-0785-04
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 EX (28ga x 20cm), L-Cath Catheter System
Code Information REF 384510, Lot Numbers 2158054, 2158055.
Recalling Firm/
Becton Dickinson Infusion Therapy
9450 South State Street
Sandy UT 84070
For Additional Information Contact
Manufacturer Reason
for Recall
Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
FDA Determined
Cause 2
Action All consignees were notified by telephone on 03/09/2004, followed by a fax letter.
Quantity in Commerce 1850 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.