Halyard 34162Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20680651341628), received between Jun 9, 2023 and Jul 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER STATED, THEY HAD A DELAY OF CASES DUE TO TEARS IN THE WRAP (DURING USE WITH PATIENTS IN THE OR). THIS WAS RESOLVED BY REPLACING THE TRAYS. IN ONE INSTANCE THE TRAY WAS ONE OF A KIND AND THEY HAD TO WAIT AN HOUR AND A HALF FOR STERILE PROCESSING TO REPLACE THE TRAY. NO INJURY WAS REPORTED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA. NO INSTRUMENTS FROM THE TRAYS WERE REPORTED AS USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252955 ↗
• InjuryJun 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER STATED, THEY HAD A DELAY OF CASES DUE TO TEARS IN THE WRAP (DURING USE WITH PATIENTS IN THE OR). THIS WAS RESOLVED BY REPLACING THE TRAYS. IN ONE INSTANCE THE TRAY WAS ONE OF A KIND AND THEY HAD TO WAIT AN HOUR AND A HALF FOR STERILE PROCESSING TO REPLACE THE TRAY. NO INJURY WAS REPORTED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA. NO INSTRUMENTS FROM THE TRAYS WERE REPORTED AS USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101609 ↗