Pump, Infusion, Enteral
General Hospital · 21 CFR 880.5725
Recent MDR events
14,912 adverse event reports on file
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00201
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00202
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00203
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices Group1722139-2026-00200
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00199
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00204
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00206
- Enteralite Infinity Enteral Feeding PumpJul 28, 2026MalfunctionMoog Medical Devices1722139-2026-00205
- Enteralite Infinity Enteral Feeding PumpJul 27, 2026MalfunctionMoog Medical Devices1722139-2026-00192
- Enteralite Infinity Orange Enteral Feeding PumpJul 27, 2026MalfunctionMoog Medical Devices1722139-2026-00190
Event type breakdown
Recalls
24 recall events for this product code
- MOOG Medical Devices GroupTerminatedJan 31, 2013
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual
The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
Z-0764-2013 · View FDA record ↗ - MOOG Medical Devices GroupTerminatedNov 15, 2012
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration
MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
Z-0294-2013 · View FDA record ↗ - CORPAK MedSystemsTerminatedOct 25, 2011
CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500.
Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure.
Z-0089-2012 · View FDA record ↗ - Zevex International, Inc.TerminatedSep 21, 2009
EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
Z-2112-2009 · View FDA record ↗ - Zevex International, Inc.TerminatedSep 21, 2009
Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
Z-2113-2009 · View FDA record ↗ - Abbott Nutrition, Abbott LaboratoriesTerminatedSep 21, 2009
Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322.
The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps, have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.
Z-2252-2009 · View FDA record ↗ - Abbott LaboratoriesTerminatedSep 20, 2008
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag
Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
Z-2305-2008 · View FDA record ↗ - Ross Products Division Abbott LaboratoriesTerminatedAug 8, 2007
Embrace Enteral Pump
Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.
Z-1141-2007 · View FDA record ↗ - Ross Products Division Abbott LaboratoriesTerminatedAug 7, 2007
The Companion ClearStar Pump System, for enteral feeding.
The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.
Z-1142-2007 · View FDA record ↗ - Ross Products Division Abbott LaboratoriesTerminatedMar 8, 2005
Flexiflo Quantum Enteral Pump
Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
Z-0570-05 · View FDA record ↗
Registered firms
71 firms currently registered for this product code
Cardinal Health
Riverview, FL, US
Jabil Circuit (singapore) Pte Ltd
Singapore Central Singapore, SG
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Cardinal Health Ireland Manufacturing Limited
TULLAMORE Offaly, IE
Baxter Healthcare Corporation
ROUND LAKE, IL, US
B. Braun Medical Inc.
Allentown, PA, US
Mainline Medical Dental Supply
North York Ontario, CA
Cardinal Medical Equipment Consulting (shanghai)co., Ltd
Shanghai, CN
Luminoah
Charlottesville, VA, US
Infusystem Inc.
Mississauga Ontario, CA
Cardinal Health
Hazelwood, MO, US
Quipment Inc.
Kennesaw, GA, US
Infusystem Inc.
Lenexa, KS, US
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Zevex, Inc.
Salt Lake City, UT, US
Primecare Medical (huzhou) Co.,ltd.
Hu zhou Zhejiang, CN
Covidien
TIJUANA, B.C. Mexico, MX
Cardinal Health D.r. 203 Ii Ltd
SANTO DOMINGO, DO
510(k) clearances
34 clearances for this product code
- LuminoahApr 20, 2026
K253558 · Luminoah FLOW Enteral Nutrition System
- Vesco Medical, LLCOct 23, 2023
K232205 · Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
- Cardinal Health, LLCDec 20, 2022
K221603 · Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI
- Amsino International, Inc.Nov 10, 2022
K220230 · AMSure Enteral Feeding Pump
- Amsino International, Inc.Sep 25, 2020
K200051 · PUGGLE Enteral Feeding Pump and Feeding Set
- CovidienJul 6, 2016
K153074 · Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
- CovidienMay 29, 2015
K143263 · Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
- CovidienDec 23, 2014
K141479 · KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS