Date Initiated by Firm |
February 03, 2005 |
Date Posted |
March 10, 2005 |
Recall Status1 |
Terminated 3 on May 17, 2005 |
Recall Number |
Z-0584-05 |
Recall Event ID |
31214 |
510(K)Number |
K032843
|
Product Classification |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
|
Product |
BD Nexiva Closed IV Catheter System, 18 gauge |
Code Information |
Catalog Numbers: 383508, 383509 Lot Numbers: All lot numbers. |
Recalling Firm/ Manufacturer |
Becton Dickinson Infusion Therapy 9450 S State St Sandy UT 84070
|
For Additional Information Contact |
Alicia Mares 801-673-3340
|
Manufacturer Reason for Recall |
The Y-luer connection may crack during normal product use.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were contacted by phone on 02/03/2005, and letters dated 02/10/05 were sent. |
Quantity in Commerce |
1500 catheters |
Distribution |
Domestic distribution: IL, UT, TX, FL. No foreign distribution. No distribution to military or VA facilities. |
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 = FOZ and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
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