McKesson 59-45HWRecalls & reported problems
Mckesson Medical-Surgical Inc. · Infant Heel Warmer Heats up to 104°F with adhesive tab , Disposable 3.75"x5.5" · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10612479153421), received between Jun 22, 2017 and Jun 22, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Overheating of Device1
Patient problems
- Burn, Thermal1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2017Overheating of Device
ONE (B)(6), CHILD WAS BROUGHT TO CLINIC FOR METABOLIC SCREENING. A HEEL WARMER WAS APPLIED TO THE LEFT FOOT FOR HEEL STICK. THE SCREENING WAS INCOMPLETE SO ANOTHER HEEL WARMER WAS PLACED ON THE RIGHT FOOT. THE SCREENING WAS COMPLETED WITH NO NOTABLE BLISTERS. ON (B)(6), TWO OTHER NURSES NOTED THAT THE HEEL WARMERS WERE TOO WARM. SUPERVISOR WAS NOTIFIED AND PRODUCT WAS WITHDRAWN FROM USE. ON JUNE 13TH, THE PARENT EMAILED A COMPLAINT AND PICTURES OF THE CHILD WITH BLISTERS ON FEET BILATERALLY. A TELEPHONE CALL WAS ATTEMPTED AND MESSAGE LEFT TO CALL CLINIC. ON JUNE 15TH, AN EMAIL WAS SENT TO THE PARENT TO CONTACT THE CLINIC. ON JUNE 19TH, THE PARENT RESPONDED STATING THAT THE CHILD WAS SEEN IN ER AND REFERRED TO A HOSPITAL BURN CENTER. THE CHILD IS RECOVERING.
Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn
MAUDE report 6666594 ↗
Other Infant Heel Warmer (Chemical Heat Pack) devices
- CARDINAL HEALTH 11460-010TCardinal Health 200, LLC · Infant heel warmer (chemical heat pack)67 reports
- Argyle MH00002TCardinal Health, Inc. · Infant heel warmer (chemical heat pack)53 reports
- NOVAPLUS V11460-010Cardinal Health 200, LLC · Infant heel warmer (chemical heat pack)38 reports
- CARDINAL HEALTH 11460-010TCardinal Health 200, LLC · Infant heel warmer (chemical heat pack)19 reports
- MEDLINE MDS138007Medline Industries, Inc. · Infant heel warmer (chemical heat pack)10 reports
- DeRoyal HNICU-100Deroyal Industries, Inc. · Infant heel warmer (chemical heat pack)2 reports
- Argyle MH00002NCardinal Health, Inc. · Infant heel warmer (chemical heat pack)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.