Monoject 8881570125Recalls & reported problems
Cardinal Health, Inc. · 0.9% Sodium Chloride,Flush Syringe, 5 mL Fill · 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 30884521005567), received between Aug 25, 2020 and Apr 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (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
- Backflow1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2021Backflow; Backflow
THE CUSTOMER REPORTED THAT WHEN THE REGISTERED NURSE PREPARES THE SALINE LOCK TO START THE IV, THEY ATTACH THE FLUSH TO LOCK AND FLUSH WITH SALINE, THEN THE SALINE EMPTIES BACK IN THE FLUSH. ADDITIONAL INFORMATION RECEIVED ON 21-APR-2021 STATED THAT WHEN THE SALINE ALL GOES BACK INTO THE SYRINGE IT DOES NOT APPEAR THAT AIR ENTERS THE SYRINGE, BUT THE CATHETER EXTENSION SET IS LEFT WITH ONLY AIR, NO FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712294 ↗MalfunctionAug 25, 2020Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO PRIME TUBING WITH THE FLUSH, IF THEY DO NOT HOLD THE PLUNGER OR CLAMP THE TUBING IT BACKS UP WITH AIR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10448249 ↗
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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