Z-0849-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 223056 units
Product Description
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
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 Pattern
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Code Information
UDI/DI 26971564466244 (Case), 16971564466247 (Box),06971564466240 (Each), Lot Numbers: 230501, 230601 and 230602