Device product
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Z-0847-2024
Product summary
- Event
- Event 93676
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 20186 units
- Official record key
device-enforcement:Z-0847-2024
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 26971564466220 (Case), 16971564466223 (Box), 06971564466226 (Each), Lot Numbers: 230503 and 230701
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.