Monoject 1180100777 (UDI 10884521013414)Recalls & reported problems
Cardinal Health, Inc. · 1 mL Tuberculin Syringe Luer-Lock Tip · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521013414), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Feb 27, 2026Open, Classified
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
Z-1768-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2023Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT THEY HAVE NOTICED NEW PACKAGING IN THE PAST TWO WEEKS AND THE BLACK PLUNGER NOW HAS TWO LINES THAT MAKE IT DIFFICULT TO READ THE EXACT MEASUREMENT, AND THE FLUID IS BUBBLING UP MORE. NURSES ARE ALSO CALLING TO SAY THAT THE SYRINGE IS NOT WORKING WITH THEIR PUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17487813 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- 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.