CARDINAL HEALTH PO7CLESRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439458398), received between Oct 10, 2019 and Oct 10, 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.

• MalfunctionOct 10, 2019Contamination /Decontamination Problem

  THE CUSTOMER STATED THAT A HAIR WAS FOUND IN THE LOWER EXTREMITY PACK, CATALOG SCVOCCTSR, THE INCIDENT CAUSED SEVERE DELAYS OF AN HOUR TO THE CASE WHERE THE CUSTOM PACK WAS GOING TO BE USED AND ALL THE INSTRUMENTS AND MATERIALS HAD TO BE STERILIZED/REPLACED AND THIS MEANT DELAYS IN THEIR PROCESS. THE PATIENT REMAINED UNDER ANESTHESIA DURING THIS TIME. THE CUSTOMER STATED THAT IT WAS AN UNEVENTFUL SURGICAL CASE AND POST OP THEREAFTER. THERE WAS NO INJURY. NO PATIENT DEMOGRAPHICS OR AN EVENT DATE WERE PROVIDED. MDR FILED BASED ON POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9176959 ↗