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Heparin Lock Flush Syringe 1 unit/mL 2 mL in 6mL SyringeRecalls & reported problems

Medefil, Inc. · Medefil 1 Unit /mL Heparin Lock Flush Syringe, 2mL fill in 6mL 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 30364253444228), received between Aug 24, 2018 and Aug 24, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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

  • Contamination /Decontamination Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 24, 2018Contamination /Decontamination Problem

    MEDEFIL RECEIVED A CALL FROM (B)(6) OF (B)(6) HOSPITAL, (B)(6) ON (B)(6) 2018 AT 10:57 AM CST STATING THAT THEY HAD FOUND ONE SYRINGE (BATCH H218321N) THAT CONTAINED WHAT APPEARED TO BE A HAIR WITHIN THE SYRINGE. WHAT APPEARED TO BE A HAIR WAS CAUGHT PRIOR TO ADMINISTRATION OF THE SYRINGE CONTENTS TO THE PATIENT. A PHOTO OF WHAT APPEARED TO BE A HAIR WAS ALSO RECEIVED ON THE SAME DAY. THE PHARMACIST COMMUNICATED THAT THE OBJECT DID NOT MOVE WHEN THE SYRINGE WAS INVERTED. HE FURTHER COMMUNICATED THAT HE PEELED BACK THE LABEL TO SEE IF IT WAS UNDER THE LABEL AND IT WAS CONFIRMED THAT IT WAS NOT UNDER THE LABEL. ON AUGUST 24, 2018 AT 10:30 AM, MEDEFIL RECEIVED THE SYRINGE WITH WHAT APPEARED TO BE A HAIR IN IT. ON AUGUST 24, 2018 AT 12:00 PM, THE QC LABORATORY EVALUATED SYRINGE CONTAMINANT USING A 100X MICROSCOPE AT A 10X AND 40X MAGNIFICATION AND IT WAS CONFIRMED TO BE A HAIR.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7815366 ↗

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 · Terminated
    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
  • Z-0600-2011 · Nov 1, 2010 · Terminated
    Medefil 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-0599-2011 · Nov 1, 2010 · Terminated
    Medefil 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-0601-2011 · Nov 1, 2010 · Terminated
    Medefil 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

All Heparin, Vascular Access Flush devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page