Monoject 8881570123Recalls & reported problems
Cardinal Health, Inc. · 0.9% Sodium Chloride,Flush Syringe, 3 mL Fill · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884521005550), received between Mar 8, 2021 and Mar 29, 2021 — classified as 3 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
- Nonstandard Device2
- Air/Gas in Device1
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.
MalfunctionMar 29, 2021Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THE ICN STAFF ARE CONCERNED THAT THERE IS A PROBLEM WITH THIS ITEMS PLUNGER. THEY¿VE DISCOVERED DURING STAFF EDUCATION AND NORMAL PATIENT CARE THAT IF THE PLUNGER PRESSURE ISN¿T MAINTAINED AFTER PRIMING, THE PLUNGER CAN RETRACT AND DE-PRIME THE EXTENSION SET PULLING FLUID AND AIR BACK INTO THE SYRINGE. THIS IS OCCURRING WHEN THE SYRINGE IS CONNECTED TO MAKE A CLOSED SYSTEM AND ALL TUBING CONNECTIONS ARE TIGHT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11584683 ↗MalfunctionMar 29, 2021Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THE ICN STAFF ARE CONCERNED THAT THERE IS A PROBLEM WITH THIS ITEMS PLUNGER. THEY¿VE DISCOVERED DURING STAFF EDUCATION AND NORMAL PATIENT CARE THAT IF THE PLUNGER PRESSURE ISN¿T MAINTAINED AFTER PRIMING, THE PLUNGER CAN RETRACT AND DE-PRIME THE EXTENSION SET PULLING FLUID AND AIR BACK INTO THE SYRINGE. THIS IS OCCURRING WHEN THE SYRINGE IS CONNECTED TO MAKE A CLOSED SYSTEM AND ALL TUBING CONNECTIONS ARE TIGHT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11584654 ↗MalfunctionMar 8, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED WHEN THEY EXPEL THE AIR AT THE TIP OF THE SYRINGE AND LET GO OF THE PLUNGER, THE PLUNGER RETRACTS AND PULLS AIR BACK INTO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11436277 ↗
Other Saline, vascular access flush devices
- BD PosiFlush 306553Becton, Dickinson And Company · Saline, vascular access flush89 reports
- Excelsior 10011Medline Industries, Inc. · Saline, vascular access flush1 recall6 reports
- ARROW IPN927748Teleflex Incorporated · Saline, vascular access flush1 recall4 reports
- Halyard SS010Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall2 reports
- Normal Saline IV Flush Syringe 10mL in 12mL syringeMedefil, Inc. · Saline, Vascular Access Flush1 recall1 report
- Excelsior E0103-01Medline Industries, Inc. · Saline, vascular access flush1 recall1 report
- McKesson 191-MIS-1130Mckesson Medical-Surgical Inc. · Saline, Vascular Access Flush1 recall0 reports
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 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
- 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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