CARDINAL HEALTH 28200-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10630140917141), received between Dec 7, 2021 and Dec 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2021Material Separation; Material Separation

  CUSTOMER REPORTED DURING A CARDIAC SURGERY, LINT RESIDUE WAS LEFT ON THE SKIN OF THE PATIENT WHEN TRYING TO REMOVE THE EXCESS CHLOREXIDINE USED TO DISINFECT SKIN OF PATIENT. THERE WAS NO ADVERSE EVENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065097 ↗
• MalfunctionDec 7, 2021Material Discolored; Material Separation; Material Discolored; Material Separation

  CUSTOMER REPORTED LINT ON TOWEL WHEN THE TOWEL GETS WET. THE ISSUE WAS NOTED BEFORE A CORONARY ANGIOGRAPHY PROCEDURE. THERE WAS NO INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956800 ↗