CARDINAL HEALTH 28700-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630140010142), received between Aug 17, 2021 and Feb 18, 2022 — classified as 2 malfunctions.

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

• MalfunctionFeb 18, 2022Material Separation; Material Separation

  CUSTOMER OPENED A PACK OF STERILE TOWELS, PRODUCT 28700-004, THAT REPORTEDLY HAD LARGE PIECES OF LINT ON THEM. THE TOWEL WAS REMOVED FROM THE PREP AREA AND NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563787 ↗
• MalfunctionAug 17, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED A CONCERN WITH THE OR TOWELS. SHE STATED THAT WHEN THE TOWELS ARE WET, THEY SHED FIBERS ONTO THEIR STERILE GLOVES. SHE NOTICED IT INITIALLY WHEN SHE WAS UNABLE TO PUSH A WIRE THROUGH A CATHETER BECAUSE IT WAS BEING STOPPED BY THE FIBERS THAT HAD FLAKED OFF INTO THE BOWL THAT THEY SOAK THEIR WIRES IN. SHE IS CONCERNED THAT MORE OF THESE FIBERS COULD HAVE GOTTEN ONTO DEVICES OR INTO PATIENTS. ACCORDING TO THE CUSTOMER, THE PROCEDURE MAY HAVE BEEN AN EMBOLIZATION, WHERE GROIN ACCESS WAS USED. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333419 ↗