Class 1 Device Recall IV Flush LLC

Date Initiated by Firm	January 26, 2005
Date Posted	March 01, 2005
Recall Status¹	Terminated ³ on September 17, 2008
Recall Number	Z-0545-05
Recall Event ID	31082
Product Classification	Heparin Lock Flush Solution - Product Code FOZ
Product	Heparin Lock Flush Solution, manufactured by IV Flush LLC
Code Information	All lots remaining on the market.
FEI Number	3004978897
Recalling Firm/ Manufacturer	IV Flush LLC 3905 Melcer, Suite 601 Rowlett TX 75088
For Additional Information Contact	972-463-7389
Manufacturer Reason for Recall	Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.
FDA Determined Cause ²	Other
Action	The firm initiated the recall by fax to distributors on 01/26/2005. On 2/16/2005 the firm faxed a second recall letter with return reciept response card to all consignees.
Distribution	Product was distributed nationwide.
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.