Equashield Equashield Male Luer Lock ConnectorRecalls & reported problems
Equashield Medical Ltd · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07290013484185), received between Jun 12, 2020 and Sep 28, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Disconnection1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Chemical Exposure1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2021Therapeutic or Diagnostic Output Failure
FAULTY EQUASHIELD. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 12546878 ↗MalfunctionJun 12, 2020Disconnection
PATIENT WAS RECEIVING 5-FU VIA CADD LEGACY PUMP WITH EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE FEMALE LL CONNECTOR SWIVEL (FC-1S) AND EQUASHIELD LUER LOCK ADAPTOR (LL-1). THE ADAPTER DISCONNECTED AND EXPOSED THE PATIENT TO 5- FU WHICH LEAD TO THE PATIENT BEING COACHED BY PHONE TO STOP THE CADD PUMP, UTILIZE A CHEMO SPILL KIT, AND THEN RETURN TO OUR FACILITY FOR ADDITIONAL TREATMENT. NEW PUMP CARTRIDGE FILLED AND STARTED ON A NEW PUMP. PATIENT HAD AN EXPOSURE TO HER HANDS AND INTO AN OPEN CUT THAT LEAD TO BURNING AND IRRITATION. TREATMENT PROVIDED BY NURSES ON SITE FOR EXPOSURE. PRIOR CHALLENGES EXPERIENCED WITH EQUASHIELD FEMALE LL CONNECTOR (FC-1) LEADING TO LEAKS, AFTER WHICH, THE COMPANY RECOMMENDED USE OF FC-1S. THIS LEAK WAS ATTRIBUTED TO DISCONNECTION OF THE LL-1. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Chemical Exposure
MAUDE report 10153222 ↗
Other Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System devices
- BD PhaSeal 515003BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall183 reports
- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- Alaris 10012241-0500BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- ICU Medical CL3011Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls26 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- ICU Medical CL3511Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls6 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page