Normal Saline IV Flush Syringe 10mL in 12mL syringeRecalls & reported problems
Medefil, Inc. · Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30364253111304), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sticking” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1619-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Sticking1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2017Sticking
**ACTUAL NDC REPORTED: (B)(4).** PT REPORTED THAT WHEN SHE PUSHED THE PLUNGER OF THE 5 ML NORMAL SALINE FLUSH SYRINGE, OFTEN-TIMES IT WOULD "STICK" AND WHEN IT RELEASED WITH FURTHER GENTLE PRESSURE, IT WOULD PUSH ENOUGH SALINE THROUGH THE SYRINGE TO "BLOW" HER VEIN. SHE HAS SMALL VEINS AND USES A SMALL BUTTERFLY NEEDLE. SHE SAID SHE DOES TRY TO "LOOSEN" THE SYRINGE PLUNGER AHEAD OF TIME BY PUSH AND PULLING IT THRU THE BARREL BUT IT STILL HAS A TENDENCY TO "STICK" MAKING IT DIFFICULT TO SLOWLY OR GENTLY START THE FLUSHING.
Patient problems: No Information
MAUDE report 6663410 ↗
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
- 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
- McKesson 191-MIS-1130Mckesson Medical-Surgical 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page