CARDINAL HEALTH 70304ARecalls & reported problems
Cardinal Health 200, LLC · PACK HOT/COLD 4.5IN X 10.5IN SOFT FREEZE PACK HEATED IN MICROWAVE FOR WARM THERAPY MEDIUM REUSABLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30888499004898), received between Jan 3, 2022 and Jan 5, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Sep 28, 2022Class IIOpen, Classified
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Z-0192-2023 · Root cause: Pending · Recall details · FDA record ↗
Most reported problems
Device problems
- Burst Container or Vessel1
- Excessive Heating1
Patient problems
- Burn(s)1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2022Excessive Heating; Excessive Heating
CUSTOMER REPORTED SECOND DEGREE BURN REPORTEDLY CAUSING BLISTERS ON INFANT¿S FOREARM. THE PRODUCT WAS REPORTEDLY HEATED ACCORDING TO PACKAGE INSTRUCTIONS WITH THE SLEEVE INCLUDED. INFANT REPORTEDLY REQUIRED THREE ADDITIONAL DAYS OF ADMISSION INCLUDING DRESSING CHANGES BY PLASTICS TEAM BEFORE BEING DISCHARGED HOME. PRODUCT DISCARDED. NO ADDITIONAL PATIENT DEMOGRAPHICS PROVIDED.
Patient problems: Burn(s)
MAUDE report 13172763 ↗MalfunctionJan 3, 2022Burst Container or Vessel; Burst Container or Vessel
CUSTOMER REPORTED HOT PACK EXPLODED DURING ACTIVATION. THE ISSUE REPORTEDLY CAUSED SKIN IRRITATION TO NURSE, BUT NO MEDICATION NEEDED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 13142574 ↗
Other Pack, hot or cold, reusable devices
- DONJOY PERFORMANCE DP163CT03-BLK-L,XLDjo, LLC · Pack, hot or cold, reusable1 recall0 reports
- DONJOY PERFORMANCE DP163CT02Djo, LLC · Pack, hot or cold, reusable1 recall0 reports
- CARDINAL HEALTH 80304ACardinal Health 200, LLC · Pack, hot or cold, reusable1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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