Monoject 8881560232Recalls & reported problems
Cardinal Health, Inc. · 60 mL Pharmacy Tray,Luer-Lock Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521012271), received between Jul 23, 2020 and Jul 23, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Most reported problems
Device problems
- Break2
- Fluid/Blood Leak2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTS THAT THE TIP OF THE 60 ML SYRINGE IS BREAKING OFF RENDERING THE SYRINGE USELESS. NO PATIENT HARM. ADDITIONAL INFORMATION STATED THAT THE SYRINGES ARE ALSO LEAKING WHEN THIS OCCURS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10313417 ↗MalfunctionJul 23, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTS THAT THE TIP OF THE 60 ML SYRINGE IS BREAKING OFF RENDERING THE SYRINGE USELESS. NO PATIENT HARM. ADDITIONAL INFORMATION STATED THAT THE SYRINGES ARE ALSO LEAKING WHEN THIS OCCURS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10313393 ↗
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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
- 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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