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U.S. Department of Health and Human Services

Class 2 Device Recall Peripherally inserted central catheter.

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  Class 2 Device Recall Peripherally inserted central catheter. see related information
Date Initiated by Firm March 25, 2005
Date Posted December 15, 2005
Recall Status1 Terminated 3 on August 08, 2011
Recall Number Z-0288-06
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 complete kit with U-Wing
Code Information REF 384425
Recalling Firm/
Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
Manufacturer Reason
for Recall
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
FDA Determined
Cause 2
Action Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Quantity in Commerce 220 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.