Heparin Lock Flush Syringe 10 Units/mL 3mL in 12mL syringeRecalls & reported problems
Medefil, Inc. · Medefil Heparin Lock Flush Syringe 10 Uniits/mL, 3 mL fill in 12 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 30364253222338), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2023
HEPARIN LOCK FLUSH LABELS ARE PUT ON CROOKED, THEREFORE, WHEN PLUNGER BROUGHT TO 1ML LINE SYRINGE ACTUALLY HAS 1.4ML MED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396537 ↗
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-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
- 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
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 100 Unit/mL 3mL in 6mL 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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