Stradis Medical, LLC HCT541BP-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M752HCT541BP20), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2022Difficult to Open or Remove Packaging Material; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Difficult to Open or Remove Packaging Material; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  CUSTOMER INDICATED THAT THE CENTRAL LINE KIT ARRIVED, WHERE THE SUPPLIES WERE PLACED ON THE BLUE"PART, WHICH MEANT THAT THE ITEMS WERE NOT ON A STERILE FIELD. HOWEVER, IT SHOULD BE NOTED THAT THE BOTH SIDES OF THE WRAP GO THROUGH THE STERILIZATION PROCESS (STRADIS STERILIZATION LOAD# M20104 AT (B)(6)) SO IN FACT THERE IS A STERILE FIELD STILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047452 ↗