Z-0854-2024 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
Product Description
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Reason for Recall
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Distribution Pattern
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Code Information
UDI/DI 50192253025819 (Case), 20192253025818 (Box), 10192253025811 (Each), Lot Numbers: 221101, 221102, 221103, 221104