Class 2 Device Recall

• Date Initiated by Firm: March 04, 2003
• Date Posted: March 27, 2003
• Recall Status: Terminated on April 14, 2004
• Recall Number: Z-0687-03
• Recall Event ID: 25779
• 510(K)Number: K932740
• Product Classification: Pump, Infusion, Elastomeric - Product Code MEB
• Product: Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065
• Code Information: Lot 262074
• FEI Number: 3011270181
• Recalling Firm/ Manufacturer: I-Flow Corporation; 20202 Windrow Dr; Lake Forest CA 92630
• For Additional Information Contact: Shane Noerhe; 949-206-2653
• Manufacturer Reason for Recall: Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
• FDA Determined Cause: Other
• Action: Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.
• Quantity in Commerce: 2,832 units
• Distribution: CA, OH, WA, TX, UT, SC, MI, IL.
• 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 = MEB