FDAFDA · Food and drugs·Recall number Z-0850-2024
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Published February 14, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
- Lot
- UDI/DI 26971564466251 (Case), 16971564466254 (Box), 06971564466257 (Each), Lot Numbers: 230501, 230701 and 230702
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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