CARDINAL HEALTH 80304ARecalls & reported problems
Cardinal Health 200, LLC · Reusable Gel Pack Insulated Medium 5.1 x 10.5 in. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00192253061362), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2023Burst Container or Vessel; Burst Container or Vessel
CUSTOMER REPORTED PATIENT HAD TOTAL ABDOMINAL HYSTERECTOMY (HAD BLOCK W/ MARCAINE & EXPAREL PRE-OP). A HEAT PACK WAS USED POST-OP FOR CRAMPING & ABDOMINAL PAIN. NURSING REPORTED HEATING PACK WAS USED PER MANUFACTURER GUIDELINES AND PLACED ABOVE THE BINDER. A SMALL BLISTERED AREA NOTED AT INCISION WITH SURROUNDING ERYTHEMA. PATIENT RETURNED TO HOSPITAL WITH CONCERN FOR BURN AT INCISION SITE AND INFECTION. SHE REQUIRED ADMISSION, PLASTIC SURGERY CONSULT, AND 2 ADDITIONAL PROCEDURES WITH XENOGRAFT PLACEMENT. PATIENT DID REPORT SHE USED HEAT ON HER ABDOMEN AFTER DISCHARGE- UNABLE TO DETERMINE TYPE OF HEATING PACK USED.
Patient problems: Blister
MAUDE report 17347427 ↗
Other Pack, hot or cold, reusable devices
- CARDINAL HEALTH 70304ACardinal Health 200, LLC · Pack, hot or cold, reusable1 recall2 reports
- 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
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
- 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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