Monoject 1180300777 (UDI 10192253033519)Recalls & reported problems
Cardinal Health 200, LLC · 3 mL Syringe Luer-Lock Tip · Class 2
All models of Monoject (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names 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
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253033519), received between Apr 13, 2024 and Apr 13, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0852-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Compatibility Problem1
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 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 19102805 ↗MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT SYRINGE LEAKAGE (PLUNGER NOT TIGHT ENOUGH, DRUG LEAKS AROUND PLUNGER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102798 ↗MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem
THE CUSTOMER REPORTED THEY NOTICED THAT THE SYRINGES HAVE THE SAME REF#, HOWEVER ARE CARDINAL BRANDED PACKAGING. THE PLUNGER ON THE CARDINAL BRAND ARE A LITTLE BIT LARGER AND THIS IS CAUSING THE INFUSION PUMPS TO REFUSE THE SYRINGE UNLESS THEY ARE "APPROVED" FOR USE IN THE INFUSION PUMPS. THE CUSTOMER IS ASKING IF WE HAVE DOCUMENTATION OR INFORMATION THAT THESE SYRINGES ARE APPROVED FOR USE IN THE INFUSION PUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102592 ↗
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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