Monoject 8881202033Recalls & reported problems
Cardinal Health, Inc. · Safety I.V. Access Combo,3 mL · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521082908), received between Jul 12, 2021 and Aug 2, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (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
- Appropriate Device Problem Term/Code Not Available2
- Nonstandard Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2021Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED WHEN USED TO ACCESS A VILE, THE BLUNT TIP CORED THE ORANGE RUBBER SEAL TOP OF THE VIAL. A PARTICLE OF THE ORANGE RUBBER WAS FOUND FLOATING IN THE SYRINGE PRIOR TO INJECTION TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12258448 ↗MalfunctionJul 14, 2021Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED WHEN USED TO ACCESS A VILE OF SOLUMEDROL SOLUTION, THE BLUNT TIP CORED THE ORANGE RUBBER SEAL TOP OF THE VIAL. A PARTICLE OF THE ORANGE RUBBER WAS FOUND FLOATING IN THE SYRINGE. THIS WAS NOTICED PRIOR TO INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12167572 ↗MalfunctionJul 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THAT A PORTION OF THE ORANGE COLORED RUBBER VIAL TOP OF THE DRUG SOLUMEDROL, WAS CORED OUT BY THE ACCESS NEEDLE AND DRAWN UP INTO THE SYRINGE WITH THE MEDS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12154495 ↗MalfunctionJul 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THAT WHEN THEY PULLED THE NEEDLE TO GET THE DRUG FROM THE VIAL, SOME PART OF THE RUBBER TOP WENT INTO THE SYRINGE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION PROVIDED ON JULY 12, 2021 STATED THAT THE DRUG BEING USED WAS SOLUMEDROL AND A PORTION OF THE ORANGE COLORED RUBBER VIAL TOP WAS CORED OUT BY THE ACCESS NEEDLE AND DRAWN UP INTO THE SYRINGE ALONG WITH THE MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12150855 ↗
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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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