Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide ...
FDA Device Recall #Z-1649-2016 — Class II — April 1, 2016
Recall Summary
| Recall Number | Z-1649-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 1, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 145 units |
Product Description
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Reason for Recall
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
Distribution Pattern
Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
Lot / 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
Other Recalls from Medtronic
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2548-2017 | Class II | SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 | May 3, 2017 |
| Z-2543-2017 | Class II | Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 4... | May 3, 2017 |
| Z-2547-2017 | Class II | CUSTOM SUTURE PACK; Item Number: US1540 and US1614 | May 3, 2017 |
| Z-2545-2017 | Class II | Best Practice Kit, Item Numbers: 00Z2064, 00Z21... | May 3, 2017 |
| Z-2544-2017 | Class II | Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 D... | May 3, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.