CARDINAL HEALTH SANRPCLMLBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439840100), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.

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

• MalfunctionJul 13, 2021Material Separation; Material Separation

  CUSTOMER REPORTED THE GAUZE C-NSG4416A FROM THE CATH LAB PACK SANRPCLMLB IS LINTING AND HAS OTHER LOOSE PARTICLES. NO ADVERSE EVENT WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER WHEN REQUESTED. REPORT BEING FILED FOR POTENTIAL RISK TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160788 ↗