Enteral Syringes With Enteral Specific Connectors
Gastroenterology, Urology · 21 CFR 876.5980
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Recent MDR events
92 adverse event reports on file
- ENFIT SYRINGEJul 16, 2026MalfunctionUnknownMW5190806
- ENFIT SYRINGEJul 9, 2026MalfunctionAvanos Medical, Inc.25761988
- ENFIT SYRINGEJul 9, 2026MalfunctionAvanos Medical, Inc.25762195
- NEO MED ORAL/ENTERAL SYRINGE WITH ENFIT CONNECTOR 60MLJul 9, 2026MalfunctionAvanos Medical, Inc25762286
- NEOMED ORAL/ENTERAL SYRINGEMay 20, 2026MalfunctionAvanos Medical, Inc.MW5188471
- ENFIT SYRINGEMay 19, 2026MalfunctionAvanos Medical, Inc.25215832
- ENFIT SYRINGEMay 19, 2026MalfunctionAvanos Medical, Inc.25215892
- ENFIT SYRINGEApr 3, 2026MalfunctionAvanos Medical, Inc.24775655
- ENFIT SYRINGEApr 3, 2026MalfunctionAvanos Medical, Inc.24775686
- AVANOS NEOMED 60ML ENTERAL SYRINGEFeb 23, 2026MalfunctionAvanos Medical, Inc.MW5184189
Event type breakdown
Recalls
4 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedFeb 2, 2024
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Z-0847-2024 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedFeb 2, 2024
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Z-0848-2024 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedFeb 2, 2024
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Z-0849-2024 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedFeb 2, 2024
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Z-0850-2024 · View FDA record ↗
Registered firms
79 firms currently registered for this product code
Avanos Medical, Inc.
Alpharetta, GA, US
Rhino Medical Supply Inc
Columbia, SC, US
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
Camedical Technology (cambodia) Co., Ltd.
Samraong Takeo, KH
Ningbo Tianyi Medical Appliance Co., Ltd.
Ningbo Zhejiang, CN
Kentec Medical, Inc.
Irvine, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Intl. Medical Industries
POMPANO BEACH, FL, US
Cardinal Health
Norfolk, NE, US
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Intelimas Corporation
Londonderry, NH, US
Vygon S A
ECOUEN 95440 Val-d'Oise, FR
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
Chengdu Sichuan, CN
American Health Packaging
Columbus, OH, US
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Cardinal Health
Hazelwood, MO, US
Medicina Ltd
Blackrod Bolton, GB
Jiangsu Caina Medical Co., Ltd
Jiangyin Jiangsu, CN
Hangzhou Best Valley Medical Technology Co., Ltd
hangzhou Zhejiang, CN
Cmt Health Pte. Ltd.
Singapore, SG
Generica Medical International
La Verne, CA, US
Clayens Crystal Lake , Llc
Crystal Lake, IL, US
Neochild, Llc
OKLAHOMA CITY, OK, US
510(k) clearances
34 clearances for this product code
- Chirana T.Injecta,A.S.Jul 1, 2026
K252483 · Enteral Syringe (20ml, 60ml)
- CMT Health PTE., Ltd.Apr 8, 2026
K253268 · Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
- CMT Health PTE., Ltd.Jul 18, 2025
K251585 · Profoject Enteral Feeding Syringe
- CardinalhealthDec 19, 2024
K243652 · Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)
- Cair LglOct 6, 2023
K231300 · Nutricair Enteral Syringe with ENFit
- Anhui Tiankang Medical Technology Co., Ltd.Aug 17, 2023
K222772 · Oral/Enteral Syringe with ENFit connector
- Pentaferte Italia S.R.L.Feb 28, 2022
K211661 · ENFit enteral syringes (NUTRIFIT)
- Jiangsu Caina Medical Co.,LtdSep 30, 2021
K211593 · Enteral Pump Syringe