Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, RE...
FDA Recall #Z-0848-2024 — Class I — December 28, 2023
Product Description
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
Reason for Recall
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.
Recalling Firm
Cardinal Health 200, LLC — Waukegan, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
60760 units
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Code Information
UDI/DI 26971564466237 (Case), 16971564466230 (Box), 06971564466233 (Each), Lot Numbers: 230501, 230502 and 230601
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated