Class 1 Device Recall IV Flush LLC

• Date Initiated by Firm: January 26, 2005
• Date Posted: March 01, 2005
• Recall Status: Terminated on September 17, 2008
• Recall Number: Z-0546-05
• Recall Event ID: 31082
• Product Classification: Sodium Chloride Injection - Product Code FOZ
• Product: Sodium Chloride Injection USP, 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: 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.