Heparin Lock Flush Syringe 100 Unit/mL 3mL in 6mL syringeRecalls & reported problems
Medefil, Inc. · Heparin Lock Flush Syringe 100 Unit/mL, 3 mL fill in 6 mL 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30364253333232), received between May 8, 2018 and May 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K092491); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
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.
MalfunctionMay 8, 2018Manufacturing, Packaging or Shipping Problem
(B)(6), REPORTED THAT THEY FOUND 5 SYRINGES WITHOUT LABELS OF HEPARIN I.V FLUSH SYRINGE, LOT #H118108N (3 ML IN 6 ML SYRIGNE). THE SYRINGES ARE PACKED IN A DISPENSER AND HAVE THE OUTER POUCH INTACT.
Patient problems: No Information
MAUDE report 7496837 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092491. One submission often covers many models, so check the product and lot details in each record.
- Z-1149-2014 · Feb 19, 2014 · TerminatedHeparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
- Z-0599-2011 · Nov 1, 2010 · TerminatedMedefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each
- Z-0600-2011 · Nov 1, 2010 · TerminatedMedefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each
- Z-0601-2011 · Nov 1, 2010 · TerminatedMedefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each m
Other Heparin, Vascular Access Flush devices
- Excelsior 60051Medline Industries, Inc. · Heparin, vascular access flush1 recall0 reports
- PENDING EMZH60051Medline Industries, Inc. · Heparin, vascular access flush1 recall0 reports
- BD PosiFlush 306424Becton, Dickinson And Company · Heparin, vascular access flush23 reports
- BD PosiFlush 306414Becton, Dickinson And Company · Heparin, vascular access flush11 reports
- BD PosiFlush 306413Becton, Dickinson And Company · Heparin, vascular access flush7 reports
- BD PosiFlush 306423Becton, Dickinson And Company · Heparin, vascular access flush4 reports
- Heparin Lock Flush Syringe 10 Units/mL 3mL in 12mL syringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
- Heparin Lock Flush Syringe 1 unit/mL 2 mL in 6mL SyringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
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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