Recall Z-0855-2024— Cardinal Health 200, LLC
Class I · Ongoing
Class I FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-12-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777. 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..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-28
- Firm location
- Waukegan, IL, United States
Product description
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.