CARDINAL HEALTH 11440-900RRecalls & reported problems
Cardinal Health 200, LLC · Instant Cold 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 20885380132053), received between Mar 4, 2019 and Mar 4, 2019 — 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
- Complaint, Ill-Defined1
- Emotional Changes1
- Pain1
- 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.
InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem
BASED ON INFORMATION RECEIVED THE PLAINTIFF ALLEGES SHE WAS INJURED BY SUFFERING A SERIOUS AND PERMANENT WOUND TO THE BACK OF HER RIGHT CALF CAUSING A SECOND DEGREE BURN INJURY WHICH REQUIRED MEDICAL TREATMENT, DIAGNOSTIC STUDIES AND OTHER MEDICAL CARE. PLAINTIFF HAS AND WILL CONTINUE TO BECOME LIABLE FOR MEDICAL COSTS ASSOCIATED WITH HER TREATMENT, HAS SUFFERED A LOSS OF WAGES AND EARNING CAPACITY, SUFFERED PSYCHOLOGICAL AND PHYSICAL PAIN AND SUFFERING AS A RESULT AS WELL AS LOSS OF ENJOYMENT OF LIFE'S PLEASURES. PLAINTIFF'S INJURIES ARE PERMANENT TO THE DEGREE THAT SHE WILL NO LONGER BE ABLE TO MAINTAIN THE SAME STATE OF WELL BEING AS BEFORE THE INCIDENT COMPLAINED OF.
Patient problems: Complaint, Ill-Defined; Emotional Changes; Pain; Partial thickness (Second Degree) Burn
MAUDE report 8385867 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page