Date Initiated by Firm |
March 09, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on June 24, 2011 |
Recall Number |
Z-0784-04 |
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 (20ga x 15cm), L-Cath Catheter System |
Code Information |
REF 384703, Lot Number 3007152 |
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 2 |
Other |
Action |
All consignees were notified by telephone on 03/09/2004, followed by a fax letter. |
Quantity in Commerce |
580 units |
Distribution |
Nationwide. Foreign distribution to Australia, Canada and Japan. |
Total Product Life Cycle |
TPLC Device Report
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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.
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