CARDINAL HEALTH 11443-012RRecalls & reported problems
Cardinal Health 200, LLC · Instant Hot Pack 6inx9in · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00888499002879), received between Oct 19, 2016 and Oct 19, 2016 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- 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.
InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT ON (B)(6) 2016, WHILE VACATIONING AT (B)(6), SHE SUSTAINED A STINGRAY BITE ON HER FOOT. CUSTOMER STATES THAT SHE FELT TERRIBLE PAIN AND SAW A LOT OF BLOOD COMING FROM THE WOUND ON HER FOOT. SHE FAINTED. WHEN SHE CAME TO, SHE STATED SHE WAS BEING ATTENDED TO BY THE LOCAL LIFEGUARDS. SHE WAS GIVEN A HOT PACK AND WAS TOLD TO GO TO THE LOCAL URGENT CARE. BY THE TIME SHE ARRIVED AT THE URGENT CARE SHE HAD THREE LARGE BLISTERS ON THE TOP OF HER FOOT.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 6042588 ↗
Other PACK, HOT OR COLD, DISPOSABLE devices
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE196 reports
- NOVAPLUS V11460-010Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE1 recall16 reports
- CARDINAL HEALTH 11443-012BCardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE56 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE37 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & ShoulderPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE1 death31 reports
- CARDINAL HEALTH 11450-040Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE20 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE14 reports
- Medline MDS139008Medline Industries, Inc. · PACK, HOT OR COLD, DISPOSABLE13 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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