CARDINAL HEALTH SAN11CPJSERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439935462), received between Apr 7, 2022 and Apr 7, 2022 — 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.

• MalfunctionApr 7, 2022Material Separation; Material Separation

  CUSTOMER HAS REPORTED AN ABUNDANCE OF LINT FROM THE BLUE COTTON OR TOWELS, PWTB04-STM, FROM THE CATH PACK, SAN11CPJSE. THE LINT IS COMING OFF DURING SURGICAL PROCEDURES AND ATTACHING TO THE WIRES. THERE HAS BEEN NO INJURY REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046337 ↗