CARDINAL HEALTH SANHDPPRVNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439196788), received between Feb 12, 2019 and Feb 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionFeb 12, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT FIBERS FROM THE BLUE OPERATING ROOM TOWELS PWTB03-STMA ARE COMING IN THE PACEMAKER PACK/SANHDPPRVN AND WERE FOUND ON THE STAFF¿S GLOVES. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS OR ADDITIONAL QUALIFYING INFORMATION WOULD BE PROVIDED BY THE CUSTOMER. THE MDR WILL BE FILED FOR MALFUNCTION AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332885 ↗