Gyrus ACMI 75URecalls & reported problems
Gyrus ACMI, LLC · Universal Stopcock Adapter Luer Lock · Class 1
- 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 00821925007321), received between Apr 22, 2024 and Apr 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (2 reports).
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
- Failure to Clean Adequately2
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.
MalfunctionApr 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE UNIVERSAL STOPCOCK HAD MULTIPLE PIECES OF FOREIGN MATERIAL ON THE WHITE PLASTIC OF THE HANDLE ASSEMBLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19168894 ↗MalfunctionApr 22, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE UNIVERSAL STOPCOCK HAD MULTIPLE PIECES OF FOREIGN MATERIAL ON THE WHITE PLASTIC OF THE HANDLE ASSEMBLY AND INSIDE THE STOPCOCK BODY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19160664 ↗
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- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.