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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 February 03, 2005
Date Posted March 10, 2005
Recall Status1 Terminated 3 on May 17, 2005
Recall Number Z-0586-05
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, 22 gauge
Code Information Catalog Numbers: 383502 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 660 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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