CARDINAL HEALTH SANHFACBM4Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439674071), received between Apr 2, 2020 and Apr 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2020Contamination /Decontamination Problem

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THEY ALLEGEDLY FOUND GRAYISH BLACK COLORED LINT BALLS IN THE PACKS AROUND TOWELS AND REPORTEDLY DURING THE PROCEDURE WHEN USING THE TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916152 ↗
• MalfunctionApr 2, 2020Device Contamination with Chemical or Other Material

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THEY ALLEGEDLY FOUND GRAYISH BLACK COLORED LINT BALLS IN THE PACKS AROUND TOWELS AND REPORTEDLY DURING THE PROCEDURE WHEN USING THE TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916079 ↗
• MalfunctionApr 2, 2020Device Contamination with Chemical or Other Material

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THEY ALLEGEDLY FOUND GRAYISH BLACK COLORED LINT BALLS IN THE PACKS AROUND TOWELS AND REPORTEDLY DURING THE PROCEDURE WHEN USING THE TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916027 ↗