FDA recall Z-0852-2024

Cardinal Health 200, LLC · Class I · device

Product

Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

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

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

Key facts

Status
Ongoing
Initiation date
2023-12-28
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0852-2024