CARDINAL HEALTH 11450-040 (REF 11450-040B)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885380167188), received between Oct 8, 2019 and Oct 5, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (17 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

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

  CUSTOMER REPORTED THAT THE STAFF MEMBER WAS TRYING TO ACTIVATE THE INSTANT HOT PACK AND IT BUSTED ALL OVER STAFF MEMBERS HAND, CLOTHES, AND SHOES AT NURSES STATION.

  Patient problems: Insufficient Information

  MAUDE report 17882650 ↗
• MalfunctionSep 14, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER HAS REPORTED THAT THEY HAVE EXPERIENCED INCIDENCES OF HOT PACKS BURSTING. THERE HAS BEEN NO INJURY OR ADVERSE EFFECT TO THE CLINICIAN AND/OR STAFF AND/OR PATIENT THAT REQUIRED ADDITIONAL MEDICAL CARE DUE TO HOT PACK BURSTING. IT IS UNKNOWN IF THE PACK MATERIAL MADE CONTACT WITH INTACT OR NON-INTACT SKIN, THE CLINICIAN AND/OR STAFF AND/OR PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744746 ↗
• MalfunctionOct 20, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE INSTANT HOT PACK BURST UPON ACTIVATION WITH NORMAL PRESSURE USED TO BREAK SEAL. HOT PACK POPPED AND THE CONTENTS BURST ALL OVER RN, IV CART, FLOOR AND BED. NO ADVERSE EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643060 ↗
• MalfunctionOct 20, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE INSTANT HOT PACK BURST UPON ACTIVATION WITH NORMAL PRESSURE USED TO BREAK SEAL. HOT PACK CONTENTS LEAKED ONTO PATIENT, BED, GLOVES. PATIENT'S SKIN WAS RINSED. THERE WAS NO ADVERSE EFFECT TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642984 ↗
• MalfunctionOct 17, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THEY HAVE HAD HOT PACKS THAT BURST WHILE STAFF IS ATTEMPTING TO ACTIVATE. THERE HAVE BEEN NO INJURIES REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613992 ↗
• MalfunctionOct 13, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HOT PACK BURST WHEN THE STAFF MEMBER ATTEMPTED TO ACTIVATE IT. NO FURTHER INFORMATION OR DEMOGRAPHICS WERE PROVIDED AFTER MULTIPLE ATTEMPTS TO REACH CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597162 ↗
• MalfunctionSep 16, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED THROUGH MEDWATCH REPORT- MW5111362. A HEALTHCARE WORKER REPORTED THAT WHILE A PATIENT WAS ACTIVATING A HOT PACK IT BURST OPEN AND SPILLED CONTENTS ONTO THE PATIENT'S BED. PATIENT STATES SHE WAS NOT BURNED BUT A SAND-LIKE SUBSTANCE GOT ON HER BED. PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440823 ↗
• MalfunctionAug 22, 2022Burst Container or Vessel; Burst Container or Vessel

  NURSE REPORTED THAT WHILE ATTEMPTING TO GIVE PATIENT A HEAT PACK, SHE HAD ONE EXPLODED ON HER. ONLY A LITTLE BIT OF THE SOLUTION GOT ON HER SKIN, BUT IT COVERED HER JACKET IN THE LEFT CHEST AND ARM AREA. THE ACTUAL PACKET WAS GIVEN TO THE CHARGE NURSE IN A ZIPLOCKED BAG, BUT NOT SAVED. NO INJURY OR OTHER DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272010 ↗
• MalfunctionJul 1, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED INSTANT HOT PACK BURST UPON ACTIVATION ON THE PATIENT'S BED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888134 ↗
• MalfunctionJun 3, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THE HOT PACK BURST, ALTHOUGH, NO ONE WAS INJURED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598525 ↗
• MalfunctionMay 7, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HOT PACK BURST OPEN WHILE THE RN WAS ATTEMPTING TO PLACE ON PATIENT. CHEMICAL SPRAYED THE FLOOR LANDING ON RN¿S SHOES. THERE WAS NO INJURY TO PATIENT OR NURSE. NO FOLLOW UP CARE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322521 ↗
• MalfunctionMar 22, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, WHILE ATTEMPTING TO ACTIVATE HEAT PACK, IT EXPLODED IN MY EYES, CHEST, HEAD, HANDS, NECK. EYE WASH WAS DONE TWO TIMES AND SALINE FLUSHES USED TO FLUSH OUT EYES. REPORTEDLY, LARGE PARTICLES OF DEBRIS REMOVED FROM MY EYES. INITIALLY I COULD NOT SEE AND HAD SEVERE BURNING TO MY EYES. AFTER FLUSHING MY EYES NO BURNING NOTED, JUST DRYNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847325 ↗
• MalfunctionDec 21, 2021Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT A CARDINAL HEALTH HOT PACK BURST ONTO A NURSE¿S SHIRT, DOWN THE LOWER HALF OF HER TRUNK AND DOWN BOTH LEGS OF HER PANTS (UPPER THIGHS AND SHINS). THERE WAS MILD SKIN IRRITATION WHERE THE CONTENTS OF THE PACKAGE CAME INTO CONTACT WITH THE SKIN. THE NURSE REPORTED THAT SHE BRUSHED OFF AS MUCH OF THE MATERIAL AS POSSIBLE WITH A WASHCLOTH AT THE TIME OF THE PACK BURSTING. ONCE HOME, SHE REMOVED CLOTHING AND WASHED HER SKIN WITH SOAP AND WATER. THE IRRITATION SUBSIDED WITH NO SIGNIFICANT OR LASTING INJURY. AT PRESENT, SHE IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056308 ↗
• MalfunctionOct 28, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT WHILE SQUEEZING TO ACTIVATE A CARDINAL HEALTH HOT PACK, FLUID FROM THE PACK SPURTED OUT ACROSS THE PATIENT¿S RIGHT ARM AND ALSO INTO THE PATIENT¿S EYE. CUSTOMER HAS INDICATED THAT THEY CANNOT PROVIDE ANY ADDITIONAL INFORMATION ON THE REPORTED INJURY, ADDITIONAL TREATMENT OR HOW THE PACK MATERIAL WAS REMOVED FROM THE PATIENT AFTER SEVERAL REQUESTS FOR THIS INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 12713194 ↗
• MalfunctionOct 25, 2021Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED A HOT PACK THAT WAS BEING UTILIZED PRIOR TO AN IV INSERTION BURST AND THE INNER CONTENTS LEAKED OUT OF THE PACKAGING AND DID REACH THE PATIENT. THERE WAS NO CONCERN OR HARM FOR THE PATIENT. NO DEMOGRAPHICS OR OTHER INFORMATION PROVIDED. REPORT BEING FILED FOR RISK TO STAFF MEMBER AND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694493 ↗
• MalfunctionSep 3, 2021Burst Container or Vessel

  CUSTOMER REPORTED HOT PACK BURST WHEN ACTIVATING IT FOR A PATIENT. THE BAG BROKE AND SPILT FLUID ON NURSE AND PATIENT BED. THE NURSE WASHED PRODUCT OFF HIS SKIN IMMEDIATELY AFTER AND REPORTEDLY HAD SLIGHT REDNESS; HOWEVER, NO ACTUAL INJURY CONFIRMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Erythema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422396 ↗
• MalfunctionJun 26, 2020Unintended Ejection

  THE NURSE WAS ACTIVATING THE HOT PACK BY SQUEEZING IT TO "POP" AND MIX THE CHEMICALS, BUT THE HOT PACK OPENED AND THE CHEMICALS SPILLED ALL OVER THEIR ARMS. THE NURSE QUICKLY WASHED THEIR ARMS AND THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10199822 ↗
• MalfunctionDec 6, 2019Temperature Problem

  CNA ATTEMPTED TO USE HEAT PACKS FOR PATIENT BUT WHEN POPPED TO ACTIVATE, HEAT PACK AUTOMATICALLY TURNED COLD INSTEAD OF WARMING UP. THE CNA REPORTED THIS HAPPENED WITH THREE DIFFERENT HEAT PACKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9426201 ↗
• MalfunctionNov 22, 2019Burst Container or Vessel

  WHEN HOT PACK WAS INITIATED, THE CONTENTS BURST OUT OF PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362355 ↗
• MalfunctionOct 8, 2019Defective Component

  RN AT HANDOFF NOTIFIED THIS RN ABOUT HEAT PACKS NOT WORKING. RN WASTED APPROXIMATELY 15-20 HEAT PACKS OVER THE COURSE OF A 12 HOURS SHIFT. HEAT PACKS DID NOT PRODUCE HEAT AFTER POPPING CENTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166120 ↗