Class I

Medical Device Recall: Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE

Cardinal Health 200, LLC · December 28, 2023

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.

Distribution

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

States Affected

NATIONWIDE

Quantity Affected

397676 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0850-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.