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Equashield Equashield Syringe Unit (UDI 07290013484031)Recalls & reported problems

Equashield Medical Ltd · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290013484031), received between Nov 12, 2020 and Mar 16, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Incomplete or Inadequate Connection1

Patient problems

  • Chemical Exposure1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 16, 2022Fluid/Blood Leak

    EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE, 5ML SYRINGE, LOT 219669A IS LEAKING FROM THE BOTTOM OF THE SYRINGE ONTO EMPLOYEE'S HAND. THERE ISN'T SUPPOSED TO BE LIQUID BENEATH THE PLUNGER. THERE IS LIQUID BENEATH THE PLUNGER AND NOT AIR. FDA SAFETY REPORT ID # (B)(4).

    Patient problems: Chemical Exposure

    MAUDE report 13798046 ↗
  • MalfunctionNov 12, 2020Incomplete or Inadequate Connection

    DEVICE NOT CONNECTING PROPERLY AS IT SHOULD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10828701 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.