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Monoject 1181200777T (UDI 10192253025811)Recalls & reported problems

Cardinal Health, Inc. · 12 mL Syringe Luer-Lock Tip · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 28, 2023Open, Classified

    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.

    Z-0854-2024 · Root cause: Process change control · FDA record ↗

  2. Sep 20, 2023Open, Classified

    Demonstrated recognition and compatibility issues with syringe infusion pumps.

    Z-0147-2024 · Root cause: Vendor change control · FDA record ↗

Other Syringe, piston devices

All Syringe, piston devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.