Class 2 Device Recall Amigo

• Date Initiated by Firm: May 07, 2004
• Date Posted: September 14, 2004
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-1335-04
• Recall Event ID: 29436
• 510(K)Number: K013309
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Amigo Insulin Infusion Pump
• Code Information: Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
• FEI Number: 3003352163
• Recalling Firm/ Manufacturer: Nipro Diabetes Systems, Inc.; 3801 Commerce Pkwy; Miramar FL 33027
• Manufacturer Reason for Recall: A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.
• FDA Determined Cause: Other
• Action: The firm will notify each distributor and user by letter and/or telephone of the recall.
• Quantity in Commerce: 8 Pumps
• Distribution: Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.
• 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 = LZG