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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Kangaroo Connect Enteral Feeding Pump

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  Class 2 Device Recall Covidien Kangaroo Connect Enteral Feeding Pump see related information
Date Initiated by Firm April 01, 2016
Create Date May 10, 2016
Recall Status1 Terminated 3 on May 18, 2018
Recall Number Z-1649-2016
Recall Event ID 73669
510(K)Number K143263  
Product Classification Pump, infusion, enteral - Product Code LZH
Product Covidien Kangaroo Connect Enteral Feeding Pump
Item Number: 584400 (OUS)

Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Code Information Serial Numbers: AS1400000006 AS1400000007 AS1400000008 AS1400000010 AS1400000011 AS1400000012 AS1400000013 AS1400000014 AS1400000015 AS1400000016 AS1400000017 AS1400000020 AS1400000022 AS1400000023 AS1400000024 AS1400000025 AS1400000026 AS1400000027 AS1400000028 AS1400000029 AS1400000031 AS1400000032 AS1400000033 AS1400000034 AS1400000035 AS1400000036 AS1400000037 AS1400000038 AS1400000039 AS1400000040 AS1400000041 AS1400000042 AS1400000043 AS1400000045 AS1400000046 AS1400000047 AS1400000049 AS1400000050 AS1400000051 AS1400000052 AS1400000054 AS1400000055 AS1400000057 AS1400000058 AS1400000059 AS1400000060 AS1400000061 AS1400000062 AS1400000063 AS1400000064 AS1400000065 AS1400000066 AS1400000067 AS1400000068 AS1400000069 AS1400000070 AS1400000072 AS1400000077 AS1400000078 AS1400000079 AS1400000080 AS1400000081 AS1400000082 AS1400000083 AS1400000089 AS1400000091 AS1400000092 AS1400000101 AS1400000103 AS1400000104 AS1400000105 AS1400000107 AS1400000108 AS1400000112 AS1400000113 AS1400000115 AS1400000116 AS1400000117 AS1400000118 AS1400000119 AS1400000120 AS1400000121 AS1400000122 AS1400000124 AS1400000126 AS1400000127 AS1400000128 AS1400000130 AS1400000131 AS1400000132 AS1400000133 AS1400000136 AS1400000139 AS1400000140 AS1400000141 AS1400000142 AS1400000143 AS1400000144 AS1400000145 AS1400000146 AS1400000148 AS1400000149 AS1400000150 AS1400000151 AS1400000152 AS1400000155 AS1400000157 AS1400000158 AS1400000160 AS1400000161 AS1400000163 AS1400000165 AS1400000166 AS1400000169 AS1400000170 AS1400000171 AS1400000173 AS1400000174 AS1400000178 AS1400000179 AS1400000180 AS1400000181 AS1400000184 AS1400000189 AS1400000190 AS1500000277 AS1500000376 AS1500000412 AS1500000416 AS1500000420 AS1500000444 AS1500000457 AS1500000479 AS1500000504 AS1500000515 AS1500000522 AS1500000526 AS1500000531 AS1500000555 AS1500000563 AS1500000711 AS1500000721 AS1500000728 AS1500000730 AS1500000739 
Recalling Firm/
Manufacturer
Medtronic
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
FDA Determined
Cause 2
Device Design
Action Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic representative or Customer Service at (800) 882-5878.
Quantity in Commerce 145 units
Distribution Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
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 = LZH and Original Applicant = COVIDIEN
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