Monoject 1180600777 (UDI 10192253034608)Recalls & reported problems
Cardinal Health 200, LLC · 6 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253034608), received between Apr 13, 2024 and Apr 14, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
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.
Reports received per month
Recalls naming this device
- 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-0853-2024 · Root cause: Process change control · FDA record ↗
- Sep 20, 2023Open, Classified
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Z-0146-2024 · Root cause: Vendor change control · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORT THAT GRADUATED LINE IS EASILY DETACHED WEAK PLUNGER, NO SUCTION, DIFFICULT TO CONTROL THE INJECTION SPEED LIQUID LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102881 ↗MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT DRUG LEAKS, PLUNGERS AND SYRINGES NOT LOCKED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102806 ↗MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT DRUG LEAKS, PLUNGERS AND SYRINGES NOT LOCKED PROPERLY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102802 ↗
Other Syringe, piston devices
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.