Device product
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
Z-0848-2024
Product summary
- Event
- Event 93676
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 60760 units
- Official record key
device-enforcement:Z-0848-2024
Official wording
Reason: 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.
Code information: UDI/DI 26971564466237 (Case), 16971564466230 (Box), 06971564466233 (Each), Lot Numbers: 230501, 230502 and 230601
Distribution pattern: Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Derived failure modes
-
Unknown
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.