CARDINAL HEALTH 11443-012B (UDI 10885380169267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10885380169267), received between Sep 3, 2019 and Oct 19, 2023 — classified as 1 injury, 55 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (56 reports).

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

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT A HOT PACK BURST WHILE OPENING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED FROM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966414 ↗
• MalfunctionOct 12, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THEY HELD THE HOT PACK AS NORMAL WITH ONE HAND AND SQUISHED IT AROUND TO DISPERSE THE HEAT AND IT WAS LEAKING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921407 ↗
• MalfunctionOct 12, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED ACTIVATING LARGE INSTANT HOT PACK FOR PATIENT USE AT CHARGE DESK WHEN IT BURST. THE CONTENTS LANDED ON CARPET FLOOR, SLEEVE, BICEP AREA, AND ON TWO SEATS. THE CONTENTS WERE BRUSHED OFF ARM, SHIRT, AND THEN NURSING SUPERVISOR OF INCIDENT (BARB) WAS NOTIFIED. HOUSEKEEPING NOTIFIED AND PRESENT FOR PROPER CLEAN UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921259 ↗
• MalfunctionOct 10, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTER THAT THE STAFF MEMBER ACTIVATED THE HOT PACK AND PLACED OVER PATIENT GOWN. NO LEAKS NOTED AT TIME OF ACTIVATION. AFTER 20 MINUTES, PRODUCT WAS FOUND TO BE LEAKING OVER PATIENT'S GOWN. STAFF MEMBER REMOVED HOT PACK, SWITCHED OUT PATIENT'S GOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17908911 ↗
• MalfunctionOct 5, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE RN WENT TO SQUEEZE THE HOT PACK TO ENGAGE HEAT AND THE CONTENTS BURST OUT THE SIDE OF THE PACKAGE. SHE STATED SHE UTILIZED PROPER TECHNIQUE WHEN TRYING TO ENGAGE THE HOT PACK. NO FURTHER INFORMATION WAS PROVIDED UPON REQUEST.

  Patient problems: Insufficient Information

  MAUDE report 17882540 ↗
• MalfunctionAug 3, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT A CARDINAL HEALTH HOT PACK BURST DURING ACTIVATION. THE PACK MATERIAL LANDED ON THE SCRUBS OF A TEAM MEMBER. THE TEAM MEMBER CHANGED SCRUBS AND WAS FINE. THEY WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450851 ↗
• MalfunctionJul 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT A PACK EXPLODED UPON ACTIVATION IN UNIT HITTING A STAFF MEMBER. NO INJURY OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375326 ↗
• MalfunctionJul 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT PACK EXPLODED UPON ACTIVATION IN NURSERY, HITTING A FATHER. NO INJURY OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375322 ↗
• MalfunctionJul 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT PACK EXPLODED UPON ACTIVATION IN UNIT HITTING A PATIENT. NO INJURY OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375269 ↗
• MalfunctionJul 21, 2023Burst Container or Vessel; Burst Container or Vessel

  PACK EXPLODED UPON ACTIVATION IN UNIT HITTING A PHYSICIAN. NO INJURY OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375257 ↗
• MalfunctionJun 13, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED EMPLOYEE SAID THAT HOT PACK EXPLODED ON HER WRIST ABOVE THE GLOVES. SHE IS NOT SURE OF THE EXACT DATE IT HAPPENED, BUT KNOW IT WAS IN APRIL. SHE WASHED OFF THE CONTENTS FROM THE HOT PACK, BUT MOST OF THE PRODUCT WAS ON THE FLOOR. THE LOT NUMBER IS NOT AVAILABLE, AND THE HOT PACK WAS DISCARDED. NO INJURY /ADVERSE EFFECT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122308 ↗
• MalfunctionJun 13, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED EMPLOYEE SAID THAT HOT PACK EXPLODED ON HER WRIST ABOVE THE GLOVES IN (B)(6). SHE WASHED IT OFF AND MOST OF THE PRODUCT WAS ON THE FLOOR. THE LOT NUMBER IS NOT AVAILABLE, AND THE HOT PACK WAS DISCARDED. NO INJURY /ADVERSE EFFECT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122306 ↗
• MalfunctionJun 6, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER IS REPORTING THAT A HOT PACK BURST WHILE ACTIVATING. THE PACK MATERIAL LANDED ON HER SHOULDER, AND IN THE BODY. SHE CLEANED IT OFF WITH WATER. THE SMELL GAVE HER A HEADACHE, BUT SHE IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072395 ↗
• MalfunctionMay 19, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED A HOT PACK BURST ON AN EMPLOYEE. THE PRODUCT LANDED ON HER CHEST AND NECK AND WAS WASHED OFF. EMPLOYEE WAS EXPOSED BUT THERE WAS NO APPARENT BURN. SHE WAS SENT FOR FIRST AID, BUT NO TREATMENT WAS NEEDED. SHE IS DOING OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963993 ↗
• MalfunctionApr 29, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED HOT PACK EXPLODED WHEN NURSE WENT TO ACTIVATE IT. NO INJURY TO STAFF OR PATIENT. PACKAGING NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841263 ↗
• MalfunctionApr 19, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, ONE HOT PACK EXPLODED WHEN AN EMPLOYEE WAS USING. OPERATOR OF THE DEVICE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773298 ↗
• MalfunctionApr 18, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED ONE HOT PACK FROM LOT V2S197 CAUSED AN EMPLOYEE INJURY WHEN IT LEAKED CONTENTS ONTO NURSE HAND. SHE RECEIVED A SECOND DEGREE BURN AND IT WAS TREATED WITH OVER-THE-COUNTER BACITRACIN. THE LEAKING HOT PACK WAS SAVED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16766153 ↗
• MalfunctionMar 29, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED AN ISSUE WITH A HOT PACK WHERE A DAD SQUEEZED IT AND THE CONTENTS SQUIRTED FROM THE TOP OF THE PACKAGE SHOOTING OUT ONTO HIM. NO INJURY REPORTED AND NO DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636438 ↗
• MalfunctionMar 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE RN ATTEMPTED TO ACTIVATE THE BAG, NOT WITH EXCESSIVE FORCE, IN PATIENT¿S ROOM. IT SPRAYED ON FLOOR AND ENVIRONMENTAL SERVICES CAME TO CLEAN IT UP IMMEDIATELY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587823 ↗
• MalfunctionMar 20, 2023Burst Container or Vessel; Burst Container or Vessel

  EMPLOYEE REPORTED ACTIVATING A HOT PACK BY SQUEEZING/BENDING THE PACK, THEN IT EXPLODED AND "LIQUID GOT ON MY LEFT HAND AND RIGHT THIGH". NOTED REDNESS TO LEFT HAND. EMPLOYEE WAS EMOTIONALLY UPSET IN THE UNIT, COMFORTED ON SCENE, THEN HAD VISIT WITH EMPLOYEE HEALTH SERVICES FOR EVENT REPORTING. LEFT HAND -ANTERIOR PALM, AND RIGHT THIGH-WERE NOT VISUALIZED BY EMPLOYEE HEALTH SERVICES. EMPLOYEE DECLINED TREATMENT AND RECEIVED NO MEDICATION.

  Patient problems: Erythema

  MAUDE report 16575506 ↗
• MalfunctionFeb 28, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED POPPING OPEN BAG AND IT RIPPED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457415 ↗
• MalfunctionFeb 22, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HOT PACK EXPLODED WHEN SQUEEZED AND WHITE MATERIAL SPEWED OUT OF THE PACKET ONTO THE HANDS OF THE TECHNICIAN. TECHNICIAN IMMEDIATELY WASHED HANDS. THERE WAS NO ADVERSE EFFECT. NO SHARP OBJECTS ARE USED TO OPEN THE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421299 ↗
• MalfunctionFeb 22, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT A TEAM MEMBER WAS INJURED WHEN THE HOT PACK BROKE OPEN. SOME OF THE PRODUCT SPLASHED INTO THE EYES. NO CLINICAL DATA OR FURTHER INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS TO REACH THE CUSTOMER. THE EVENT DATE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16421294 ↗
• MalfunctionFeb 17, 2023Burst Container or Vessel; Burst Container or Vessel

  HOT PACK WAS BEING ACTIVATED IN PATIENTS¿ ROOM WITH NORMAL PRESSURE APPLIED WHEN IT BURST AND THE CONTENTS WENT ONTO THE FLOOR. THE CONTENTS WERE CLEANED UP IMMEDIATELY. NONE OF THE CONTENTS LANDED ON THE PATIENT OR ON THE HEALTHCARE WORKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400307 ↗
• MalfunctionFeb 17, 2023Burst Container or Vessel; Burst Container or Vessel

  HEALTHCARE PROVIDER WAS IN THE PROCESS OF ACTIVATING AN INSTANT HOT PACK WHEN IT BURST, AND THE CONTENTS WENT ONTO THE FLOOR AND ON THE JACKET OF THE HEALTHCARE PROVIDER. THE HEALTHCARE PROVIDER REMOVED THE JACKET, AND THE CONTENT DID NOT REACH SKIN. THERE WAS NO HARM TO PATIENT OR HEALTHCARE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400178 ↗