Equashield Equashield Female Luer Lock ConnectorRecalls & reported problems
Equashield Medical Ltd · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290013484178), received between Jun 12, 2020 and Aug 22, 2023 — classified as 3 malfunctions.
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
- Leak/Splash1
Patient problems
- Chemical Exposure1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2023
UPON ADMINISTRATION OF CHEMOTHERAPY LEAKING WAS NOTED FROM EQUASHIELD CONNECTION DEVICE. CHEMO PAUSED. DEVICE WAS INSPECTED AND FOUND TO BE FIRMLY CONNECTED FROM MALE TO FEMALE DEVICE. MALE DEVICE CHANGED AND RECONNECTED. CHEMO CONTINUED TO HAVE SLOW LEAK. FEMALE CONNECTOR CHANGED W/ NO FURTHER LEAKS DETECTED. ALL CHEMO PROPERLY AND SAFELY CONTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17595049 ↗MalfunctionOct 29, 2021Leak/Splash
MEDICATION WAS DRIPPING OUT OF THE CONNECTION FROM THE TUBING. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Insufficient Information
MAUDE report 12727937 ↗MalfunctionJun 12, 2020Fluid/Blood Leak
PATIENTS RECEIVING 5-FU VIA CADD LEGACY PUMP WITH EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE FEMALE LL CONNECTOR (FC-1) EXPERIENCED LEAKAGE DUE TO THE CONNECTOR LEADING TO CHEMOTHERAPY EXPOSURE AND USE OF PROVIDED SPILL KITS. ALL PATIENTS EXPERIENCED CHALLENGE FROM THE IMPLEMENTATION OF THE PRODUCT LEADING TO REPORT WITH THE COMPANY. THE COMPANY'S RECOMMENDATION WAS TO USE FEMALE LL CONNECTOR SWIVEL (FC-1S). FDA SAFETY REPORT ID# (B)(4).
Patient problems: Chemical Exposure
MAUDE report 10153246 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.