MalfunctionMPO

CARDINAL HEALTH

Received Apr 7, 2026 · Event occurred Mar 8, 2026

Report 24799412 · MDR key 24799412

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Cardinal Health 200, Llc

Model number

11460-010T

Catalog number

11460-010T

Lot number

VN25284A29

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON [REDACTED], INFANT HEEL WARMER WHEN ACTIVATED ARE ACTIVATING COLD SIMILAR TO A CHEMICAL ICE PACK. AT LEAST 4 PACKS WITH THE SAME LOT # ARE REACTING THIS WAY. MANUFACTURER RESPONSE FOR INFANT HEEL WARMER (CHEMICAL HEAT PACK), CARDINAL HEALTH (PER SITE REPORTER). REPORTED TO CARDINAL ON [REDACTED].