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U.S. Department of Health and Human Services

Class 2 Device Recall Introducer catheter

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  Class 2 Device Recall Introducer catheter see related information
Date Initiated by Firm February 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 10, 2004
Recall Number Z-0587-04
Recall Event ID 28397
510(K)Number K974764  
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Product BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
Code Information Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.
Recalling Firm/
Becton Dickinson Infusion Therapy
9450 South State Street
Sandy UT 84070
For Additional Information Contact
Manufacturer Reason
for Recall
Splittable catheter introducer may not fully split or may separate non-uniformly.
FDA Determined
Cause 2
Action On 02/03/2004, all consignees were notified by telephone and letter.
Quantity in Commerce 12000 units
Distribution Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
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.