CARDINAL HEALTH SAN57PD00JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439212266), received between Sep 11, 2019 and Sep 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionSep 11, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT THE OR TOWEL IN THEIR PEDIATRIC CARDIAC CATH PACK WAS LINTING. PER CUSTOMER, THIS WAS "CAUGHT JUST IN TIME" AND THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION ABOUT THE PATIENT, THE PROCEDURE, OR THE EVENT DATE WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8993008 ↗