Class 2 Device Recall

• Date Initiated by Firm: March 05, 2003
• Date Posted: April 03, 2003
• Recall Status: Terminated on December 01, 2004
• Recall Number: Z-0709-03
• Recall Event ID: 25777
• 510(K)Number: K923875
• Product Classification: Pump, Infusion - Product Code FRN
• Product: Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
• Code Information: Lot numbers: 262111 (manufactured June 2002, expires May 2005) 282233 (manufactured August 2002, expires July 2005)
• Recalling Firm/ Manufacturer: I-Flow Corporation; 20202 Windrow Dr; Lake Forest CA 92630
• For Additional Information Contact: Shane Noehre; 949-206-2653
• Manufacturer Reason for Recall: Wrong component may result in over infusion of medications.
• FDA Determined Cause: Other
• Action: Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.
• Quantity in Commerce: 5,808 units
• Distribution: States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.
• 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 = FRN