CARDINAL HEALTH 11460-010T (UDI 10630140017391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10630140017391), received between Oct 20, 2016 and Jun 13, 2024 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (66 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Burst Container or Vessel; Burst Container or Vessel

  INFANT HEEL WARMER BURST WHILE WARMING. THERE HAS BEEN NO INJURY REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533077 ↗
• MalfunctionJun 11, 2024Burst Container or Vessel; Burst Container or Vessel

  EXPLODED IN THEIR HANDS WHILE THEY WERE WARMING INFANTS HEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515762 ↗
• MalfunctionJun 11, 2024Burst Container or Vessel; Burst Container or Vessel

  EXPLODED IN THEIR HANDS WHILE THEY WERE WARMING INFANTS HEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511551 ↗
• MalfunctionJun 8, 2024Burst Container or Vessel; Burst Container or Vessel

  INFANT HEEL WARMER BURST WHILE WARMING. THERE HAS BEEN NO INJURY REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494486 ↗
• MalfunctionJun 7, 2024Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED INFANT HEEL WARMER EXPLODED IN THEIR HANDS WHILE THEY WERE WARMING INFANTS' HEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488437 ↗
• MalfunctionJun 1, 2024Burst Container or Vessel; Burst Container or Vessel

  MW: (B)(4). EMPLOYEE ¿CRACKED¿ THE HEEL WARMER, PER INSTRUCTIONS. THE HEEL WARMERS CONTENTS EXPLODED OUT OF THE TOP AND LANDED ON EMPLOYEE. THIS INCLUDED THE CONTENT GETTING INTO HER RIGHT EYE. THE EMPLOYEE WAS SEEN BY EMPLOYEE HEALTH AND CLEARED TO RETURN TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442132 ↗
• MalfunctionJan 11, 2024Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER STATED THAT WHILE HER SON WAS IN THE NICU, ONE OF THE STAFF MEMBERS SQUEEZED/TWISTED THE HEEL WARMER SO TIGHTLY THAT IT BUSTED AND SOME OF THE CONTENTS GOT ON HER SON AND HUSBAND. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499856 ↗
• MalfunctionJan 11, 2024Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER STATED THAT WHILE HER SON WAS IN THE NICU, ONE OF THE STAFF MEMBERS SQUEEZED/TWISTED THE HEEL WARMER SO TIGHTLY THAT IT BUSTED AND SOME OF THE CONTENTS GOT ON HER SON AND HUSBAND'S BODY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499833 ↗
• MalfunctionSep 28, 2023Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED THAT A LAB TECH WAS PREPARING TO USE A CARDINAL HEALTH INFANT HEEL WARMING PACK. WHEN SHE SQUEEZED THE POUCH AS DIRECTED FOR USE THE PACK BURST IN HER FACE. THE CONTENTS WENT INTO HER RIGHT EYE, NOSE, AND MOUTH. SHE WAS IMMEDIATELY TAKEN TO THE EYE WASH STATION WHERE SHE CONTINUOUSLY RINSED THE EYE AS WELL AS RINSED HER MOUTH SEVERAL TIMES. THE REMAINING SUBSTANCE WAS WIPED FROM HER FACE, AND SHE WAS TRANSFERRED TO THE EMERGENCY ROOM. THE ISSUE RESULTED IN A SCRATCH ON HER EYE AND A FOLLOW UP WITH OPHTHALMOLOGY. SHE WAS GIVEN AN ANTIBIOTIC EYE DROP AND MISSED ONE DAY OF WORK. SHE IS DOING WELL AND THERE ARE NO RESIDUAL ISSUES.

  Patient problems: Corneal Abrasion

  MAUDE report 17834463 ↗
• MalfunctionAug 24, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THE INFANT HEEL WARMER BURST DURING ACTIVATION AND THE CONTENTS LANDED ON THE NURSE'S SCRUBS. THE CONTENTS WERE WASHED OFF WITH WATER. NO PATIENT INJURY REPORTED AND NO RESIDUAL COMPLAINTS NOTED. WE HAVE REMOVED THE LOT NUMBER FROM THE FLOORS AND PATIENT ROOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610726 ↗
• MalfunctionAug 10, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDWATCH REPORT (B)(4); IT HAS BEEN REPORTED THAT A HEEL WARMER BURST WHILE A NURSE WAS ACTIVATING. THE CONTENTS LANDED ON THE NURSE¿S CLOTHING AND ON THE FLOOR. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497572 ↗
• MalfunctionAug 3, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT A LABORATORY SUPPORT TECHNICIAN WAS ACTIVATING THE HEEL WARMER BY SQUEEZING IT, THE TOP OF THE HEEL WARMER BUSTED OPEN. THERE WAS NO INJURY/ADVERSE EVENT. THE PACK MATERIAL GOT ON THE CLINICIAN'S CLOTHES. THERE WAS NO SKIN CONTACT. IT WAS WASHED AWAY WITH SOAP AND WATER. THE CLINICIAN WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454208 ↗
• MalfunctionJul 25, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, STAFF MEMBER SQUEEZED NEWBORN HEEL WARMER TO ACTIVATE AND THE GEL LEAKED OUT. IMMEDIATELY UPON SQUEEZING, THE PRODUCT PACKAGING SEPARATED ALONG AN EDGE CAUSING A HOLE AND INNER CONTENTS TO LEAK OUT. CUSTOMER FEARS STAFF OR PATIENT COULD BE HURT FROM WARMER LEAKING OUT. NO INJURY TO PATIENT OR STAFF FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393916 ↗
• MalfunctionJul 25, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, STAFF MEMBER SQUEEZED NEWBORN HEEL WARMER TO ACTIVATE AND THE GEL LEAKED OUT. IMMEDIATELY UPON SQUEEZING, THE PRODUCT PACKAGING SEPARATED ALONG AN EDGE CAUSING A HOLE AND INNER CONTENTS TO LEAK OUT. CUSTOMER FEARS STAFF OR PATIENT COULD BE HURT FROM WARMER LEAKING OUT. NO INJURY TO PATIENT OR STAFF FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393912 ↗
• MalfunctionJul 25, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, STAFF MEMBER SQUEEZED NEWBORN HEEL WARMER TO ACTIVATE AND THE GEL LEAKED OUT. IMMEDIATELY UPON SQUEEZING, THE PRODUCT PACKAGING SEPARATED ALONG AN EDGE CAUSING A HOLE AND INNER CONTENTS TO LEAK OUT. CUSTOMER FEARS STAFF OR PATIENT COULD BE HURT FROM WARMER LEAKING OUT. NO INJURY TO PATIENT OR STAFF FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393895 ↗
• MalfunctionJul 14, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT A CARDINAL HEALTH HEEL WARMER BURST WHILE BEING ACTIVATED BY A NURSE, LANDING IN HER EYE. PAIN AND REDNESS OF RN¿S EYE WAS NOTED, THE EYE WAS FLUSHED WITH SALINE, AND NO OTHER MEDICATION WAS PROVIDED. THE PACK MATERIAL WAS REMOVED BY COLD WATER IN THE SINK. THE NURSE REPORTED NO ISSUES AFTER THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328020 ↗
• MalfunctionMay 22, 2023Burst Container or Vessel; Burst Container or Vessel

  KAISER INFUSION CENTER NURSE WAS PREPARING THE CARDINAL HEALTH INFANT HEEL WARMER PER PRODUCT INSTRUCTIONS WHEN THE PRODUCT BURST OPEN, AND CONTENTS LEAKED UNTO HIS UPPER THIGHS. THANKFULLY, THE CONTENTS ONLY CAME IN CONTACT WITH HIS SCRUBS. HE REMOVED HIS SCRUBS AND IS DOING WELL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16980580 ↗
• MalfunctionFeb 2, 2023Burst Container or Vessel; Burst Container or Vessel

  NIGHT SHIFT NICU RN OPENED AN INFANT HEEL WARMER AND IT DID NOT ACTIVATE. THE POWDER CAME OUT THROUGH THE TOP AND GOT IN THE RN'S EYE. SHIFT SUPERVISOR WAS NOTIFIED AND CALLED POISON CONTROL FOR INSTRUCTION ON EXPOSURE. RN FLUSHED EYE AT TIME OF CONTACT AND USED ARTIFICIAL TEARS FOR TREATMENT. RN HAVING NO PAIN OR FURTHER COMPLICATIONS.

  Patient problems: Discomfort

  MAUDE report 16287435 ↗
• MalfunctionFeb 2, 2023Burst Container or Vessel; Burst Container or Vessel

  NIGHT SHIFT NICU RN OPENED AN INFANT HEEL WARMER AND IT DID NOT ACTIVATE. THE POWDER CAME OUT THROUGH THE TOP AND GOT IN THE RN'S EYE. SHIFT SUPERVISOR WAS NOTIFIED AND CALLED POISON CONTROL FOR INSTRUCTION ON EXPOSURE. RN FLUSHED EYE AT TIME OF CONTACT AND USED ARTIFICIAL TEARS FOR TREATMENT. RN HAVING NO PAIN OR FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287367 ↗
• MalfunctionJan 3, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN THE BEDSIDE NURSE WAS SQUEEZING THE INFANT HEEL WARMER FOR ACTIVATION, IT EXPLODED ON HER SCRUB TOP. NO ADVERSE EFFECT OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088279 ↗
• MalfunctionNov 22, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, WE ARE HAVING ISSUES WITH THE HEEL WARMERS BUSTING AND THE CONTENTS GOT INTO THE PATIENT'S CAREGIVER EYE. NO MEDICATION WAS GIVEN, BUT THE CAREGIVER EYES WERE FLUSHED. I WOULD LIKE TO REPORT IT AS A PRODUCT FAILURE. NO DEMOGRAPHICS OR ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843465 ↗
• MalfunctionNov 16, 2022Device Handling Problem; Device Handling Problem

  WHEN THE NURSE WENT TO ACTIVATE THE PACKAGE IT EXPLODED INTO HER HAND. SHE WAS NOT HURT, SHE QUICKLY WASHED IT OFF SHE STATED IT WAS A SLIGHT BURNING SENSATION BUT NOTHING ELSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803869 ↗
• MalfunctionNov 4, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER HAS REPORTED THAT THE CARDINAL HEALTH INFANT HEEL WARMER BURST WHILE ACTIVATING. THERE HAS BEEN NO INJURY REPORTED AND THE EVENT DATE IS UNKNOWN. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735129 ↗
• MalfunctionSep 24, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN THE HEEL WARMER WAS SQUEEZED TO ACTIVATE, ITS CONTENTS OOZED OUT ON ASSOCIATE. NO INJURY REPORTED OR OTHER DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481348 ↗
• MalfunctionSep 24, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN THE HEEL WARMER WAS SQUEEZED TO ACTIVATE, ITS CONTENTS OOZED OUT ON ASSOCIATE¿S HANDS. NO INJURY REPORTED OR OTHER DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481314 ↗