CARDINAL HEALTH 11443-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888499004880), received between Feb 7, 2019 and Aug 24, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2019Explosion; Material Split, Cut or Torn

  EMERGENCY DEPARTMENT TECH ACTIVATED THE HOT PACK AND IT EXPLODED WITH THE CONTENTS HITTING HIS FACE AND EYE. THERE IS A TEAR IN THE CORNER OF THE HOT PACK WHERE THE CONTENTS CAME OUT. NO SERIOUS INJURY RESULTED FROM THIS MISHAP.

  Patient problems: Chemical Exposure

  MAUDE report 8928738 ↗
• InjuryMay 9, 2019Material Rupture

  BASED ON THE REPORT WE RECEIVED BY THE CUSTOMER, THE HOT PACK REPORTEDLY BURST DURING ACTIVATION, AND ONE EMPLOYEE WAS TREATED IN THE EMERGENCY DEPARTMENT WITH A SALINE FLUSH TO EYES, FACE AND NECK.

  Patient problems: Injury

  MAUDE report 8595040 ↗
• InjuryFeb 7, 2019Material Rupture

  PER THE CUSTOMER, THEY REPORTEDLY HAD A HOT PACK BURST, WHICH ALLEGEDLY LEAD TO A PERSONAL INJURY. NO INFORMATION REGARDING THE ACTUAL INCIDENT OR PERSON WAS PROVIDED TO CARDINAL HEALTH.

  Patient problems: Injury

  MAUDE report 8315019 ↗
• InjuryFeb 7, 2019Burst Container or Vessel

  PER THE CUSTOMER, THEY REPORTEDLY HAD A HOT PACK BURST, WHICH ALLEGEDLY LEAD TO A PERSONAL INJURY. NO INFORMATION REGARDING THE ACTUAL INCIDENT OR PERSON WAS PROVIDED TO CARDINAL HEALTH.

  Patient problems: Injury

  MAUDE report 8314930 ↗