Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
FDA Recall #Z-0857-2024 — Class I — December 28, 2023
Product Description
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
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.
Recalling Firm
Cardinal Health 200, LLC — Waukegan, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Code Information
UDI/DI 50192253025833 (Case), 20192253025832 (Box), 10192253025835 (Each), Lot Numbers: 221101, 230601
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated