CARDINAL HEALTH 11443-512BRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885380168406), received between Nov 30, 2021 and Dec 5, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Burst Container or Vessel; Burst Container or Vessel

  PER MEDWATCH REPORT #(B)(4), AFTER POPPING HOT PACK, USER NOTED CRYSTALIZING SUBSTANCE COMING OUT FROM HOT PACK WITH NO INJURY TO THE PATIENT. INTENDED PROCEDURE WAS TO PLACE HOT PACK ON ARM TO HELP FIND VEINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269230 ↗
• MalfunctionSep 3, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED WHILE STARTING TO PREP OUR PATIENT, A VISITING NURSE FROM ANOTHER FLOOR WHO WAS SHADOWING ME FOR IV INSERTION TRAINING AND WAS OPENING A WARM COMPRESS. SHE POPPED THE HOT PACK, AND IT SQUIRTED ALL OVER MY FACE, HAIR, UPPER AND LOWER BODY. THE WHITE MATERIAL CRYSTALIZED ON MY BODY, AND I HAD TO GO WASH IT OFF AND CHANGE MY SCRUBS. THERE WERE NO INJURIES, AND THE PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675038 ↗
• MalfunctionApr 14, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT IN OUR 4TH FLOOR CHEMO, SEVERAL NURSES EXPERIENCED HOT PACKS THAT EXPLODED WHEN THEY WERE ABOUT TO USE THEM ON PATIENTS. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745430 ↗
• MalfunctionApr 14, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT IN OUR 4TH FLOOR CHEMO, SEVERAL NURSES EXPERIENCED HOT PACKS THAT EXPLODED WHEN THEY WERE ABOUT TO USE THEM ON PATIENTS. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745264 ↗
• MalfunctionApr 14, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT IN OUR 4TH FLOOR CHEMO, SEVERAL NURSES EXPERIENCED HOT PACKS THAT EXPLODED WHEN THEY WERE ABOUT TO USE THEM ON PATIENTS. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745070 ↗
• MalfunctionApr 14, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT IN OUR 4TH FLOOR CHEMO, SEVERAL NURSES EXPERIENCED HOT PACKS THAT EXPLODED WHEN THEY WERE ABOUT TO USE THEM ON PATIENTS. NO ADVERSE AFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744664 ↗
• MalfunctionFeb 2, 2023Burst Container or Vessel; Burst Container or Vessel

  WHILE ACTIVATING THE HEAT PACK TO WARM A PATIENT¿S HAND THE HEAT PACK BURST, AND THE CONTENTS WENT INTO TEAM MEMBER¿S RIGHT EYE. SHE WAS TAKEN TO THE EMERGENCY DEPARTMENT. THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED AFTER MAKING SEVERAL REQUESTS FOR CLINICAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284529 ↗
• MalfunctionSep 16, 2022Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  CUSTOMER REPORTED THAT WHEN THE HOT PACK WAS ACTIVATED IT HAD SOME LEAKING. NO HARM NOTED TO THE USER OR PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442099 ↗
• MalfunctionSep 9, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED WHEN ACTIVATING THE WARM PACK, ITS CONTENT BURST OUT OF THE PACKAGING LANDING ON PATIENT¿S HAIR (TOP OF HEAD), EYEBROWS AND CHEST; PATIENT STATED SHE ALSO TASTED THE CONTENT OF THE WARM PACK. CONTENTS WASHED OFF BY PATIENT AND CLINICIAN. SKIN REMAINED INTACT AND NO SKIN/EYE IRRITATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396536 ↗
• MalfunctionApr 20, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN ACTIVATING THE PACK BY SQUEEZING, THE PACK BURST CAUSING CONTENTS TO LAND ON PATIENTS CHEEK. THE PACK MATERIAL WAS WASHED OFF PATIENT WITH SOAP AND WATER. THERE IS NO INJURY OR ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161471 ↗
• MalfunctionNov 30, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT WHILE A NURSE WAS ACTIVATING A CARDINAL HEALTH HOT PACK, THE PACK BURST, AND GEL FELL ON HER. THE NURSE IS OKAY, AND THE PACK MATERIAL WAS REMOVED WITH SOAP AND WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901079 ↗