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U.S. Department of Health and Human Services

Class 2 Device Recall Amigo

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  Class 2 Device Recall Amigo see related information
Date Initiated by Firm May 07, 2004
Date Posted September 14, 2004
Recall Status1 Terminated 3 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.
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 2
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 and Original Applicant = NIPRO DIABETES SYSTEMS, INC.
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