Equashield Equashield Syringe Unit (UDI 07290013484055)Recalls & reported problems
Equashield Medical Ltd · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290013484055), received between Nov 12, 2020 and Feb 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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.
Reports received per month
Most reported problems
Device problems
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2024
WHILE DRAWING UP PERTUZUMAB INTO AN EQUASHIELD SYRINGE, WE NOTICED THERE WAS A FLOATING PIECE OF WHAT APPEARS TO BE BLACK RUBBER. WE BELIEVE THE FLOATING BLACK PIECE MAY BE FROM THE PLUNGER OF THE EQUASHIELD SYRINGE. IT IS ALSO POSSIBLE THAT IT ORIGINATED FROM THE PERTUZUMAB VIAL. REFER TO ADDITIONAL DOCUMENTS IN I2K.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18799588 ↗MalfunctionNov 12, 2020Incomplete or Inadequate Connection
ISSUE WITH CONNECTION DEVICE AND ATTACHING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10828746 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.