Monoject 8881516200Recalls & reported problems
Cardinal Health, Inc. · 6 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 10884521012127), received between May 21, 2019 and Aug 31, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Contamination1
- Material Puncture/Hole1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2020Contamination; Contamination
THE CUSTOMER REPORTED THAT THEY FOUND A TINY PIECE OF CARDBOARD INSIDE THE BARREL OF THE SYRINGE, ON THE SHAFT OF THE PLUNGER. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10474042 ↗MalfunctionMay 21, 2019Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED WHILE THE DOCTOR WAS DOING A BLOCK, THE SYRINGE SQUIRTED OUT THE SIDE. IT DID NOT HIT THE PATIENT OR THE DOCTOR, THERE WAS NO INJURY TO THE PATIENT OR THE DOCTOR, HOWEVER, AS A PRECAUTION THE DOCTOR ORDERED IV ANTIBIOTICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8627929 ↗
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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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