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Devices
Device Recall Amigo
Model / Serial
Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.
Product Description
Amigo Insulin Infusion Pump
Manufacturer
Nipro Diabetes Systems, Inc.
1 Event
Recall of Device Recall Amigo
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Manufacturer
Nipro Diabetes Systems, Inc.
Manufacturer Address
Nipro Diabetes Systems, Inc., 3801 Commerce Pkwy, Miramar FL 33027
Source
USFDA
Language
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