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Recall Observatory FDA recall evidence

Device product

Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777

Z-0855-2024

December 28, 2023

Class I

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 93676
Status
Ongoing
Classification
Class I
Quantity
Unavailable
Official record key
device-enforcement:Z-0855-2024

Official wording

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 information: UDI/DI 50192253034675 (Case), 20192253034674 (Box), 10192253034677 (Each), Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.