FDA Enforcement
Class I
Ongoing
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
Recall: Z-0856-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0856-2024
- Event ID
- 93676
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 28, 2023
- Classification Date
- February 2, 2024
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States
Description
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
Reason
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.
Code Info
UDI/DI 50192253034699 (Case), 20192253034698 (Box), 10192253034691 (Each), Lot Numbers: 221201, 230201, 230601, 230602
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.