FDAFDA · Food and drugs·Recall number Z-0851-2024
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Published February 14, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
- Lot
- UDI/DI 50192253034538 (Case), 20192253034537 (Box), 10192253034530 (Each), Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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