AMSafe ® Pre-Filled Normal Saline Flush Syringe 1Recalls & reported problems
Amsino International, Inc. · AMSafe ® Pre-Filled Normal Saline Flush Syringe , 10 mL 0.9% Sodium Chloride Injection, USP · Class 2
Data updated Oct 18, 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 30704411015141), received between Jan 12, 2026 and Jan 12, 2026 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026
10ML SALINE FLUSH WAS FILLED WITH AIR INSTEAD OF FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031473 ↗MalfunctionJan 12, 2026
FLUSH PLUNGER BROKE OFF THE BACK WHILE TRYING TO ADMINISTER MEDICATIONS AND SPILLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031472 ↗
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
- Halyard SS003Owens & Minor Distribution, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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