Hospira 795123Recalls & reported problems
ICU Medical, Inc. · 100 mL EMPTY CONTAINER · Class 2
All models of Hospira (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10887787006831), received between Sep 18, 2024 and Feb 24, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Particulates” (10 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Particulates10
- Fluid/Blood Leak2
- Air/Gas in Device1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Particulates
EVENT OCCURRED REGARDING AN EMPTY LIFECARE CONTAINER 100 ML SIZE WHERE THEY REPORTED THAT THEY HAVE BEEN SEEING FIBER LIKE MATERIAL FLOATING IN POST-PRODUCTION PRODUCT. PREMIXED DRUGS THEY ARE MANUFACTURING - FENTANYL, KETAMINE, HYDROMORPHONE. THEY HAVE NOT HAD ANY INCIDENTS WITH PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437587 ↗MalfunctionFeb 20, 2026Particulates
A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR HYDROMORPHONE (BATCH: 50953) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24406226 ↗MalfunctionFeb 19, 2026Particulates
A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 50161) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397249 ↗MalfunctionFeb 19, 2026Particulates
A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 50675) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397246 ↗MalfunctionFeb 19, 2026Particulates
A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 50837) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397238 ↗MalfunctionFeb 19, 2026Particulates
A COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50632 ) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24395265 ↗MalfunctionFeb 19, 2026Particulates
A COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50660) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24395251 ↗MalfunctionFeb 19, 2026Particulates
A COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 49926) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24395238 ↗MalfunctionDec 12, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE ENTIRE PORT OF A EMPTY LIFECARE CONTAINER 100 ML SIZE REPORTEDLY CAME OUT UPON OPENING THE BAG AND UNSPECIFIED FLUID/SOLUTION FELL ONTO THE FLOOR. THIS PRODUCT ISSUE WAS NOTED WHEN THE STAFF WENT TO OPEN THE ACCESS PORT FOR A PATIENT'S INFUSION. THERE WAS NO REPORT OF ANY HUMAN HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23795468 ↗MalfunctionJun 27, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device
A EMPTY LIFECARE CONTAINER 100 ML SIZE THAT REPORTEDLY LEAKED WATER OR AIR. PATIENT INVOLVEMENT IS UNKNOWN BUT THERE WAS NO PATIENT HARM/ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350269 ↗MalfunctionApr 30, 2025Particulates; Particulates
A COMPLAINT WAS RECEIVED REGARDING AN EMPTY LIFECARE CONTAINER 1000 ML SIZE THAT EXPERIENCED PARTICULATE MATTER. REPORT STATED THAT THEY HAVE BEEN MONITORING THE INSTANCES OF PARTICLES FOUND IN THE ICU MEDICAL BAGS AFTER COMPOUNDING FOR MANY MONTHS. IT HAS TYPICALLY BEEN A VERY LOW LEVEL, A FEW BAGS EVERY FEW BATCHES COMPOUNDED WOULD HAVE TINY PARTICLES THAT THE VISUAL INSPECTOR WOULD CATCH AFTER COMPOUNDING. HOWEVER, RECENTLY THERE HAS BEEN A LARGE INCREASE IN PARTICLES. THIS LEADS TO REJECTION OF THE BAG OF COMPOUNDED MEDICINE. SAMPLE VIDEO PROVIDED SHOWING THE INSTANCES OF PARTICLES FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940015 ↗MalfunctionSep 18, 2024Particulates; Particulates
A COMPLAINT ON AN UNKNOWN DATE INVOLVING A EMPTY LIFECARE CONTAINER 100ML SIZE EXPERIENCED FOREIGN MATTER. THE REPORTER STATED THAT BAG WAS FOUND TO HAVE PARTICULATE MATTER INSIDE. THE REPORTER ADDED THAT THEY NOTICED THE PLASTIC PARTICULATE MATTER INSIDE THE BAG ONCE THE BAG WAS SPIKED AND THE DILUENT AND/OR DRUG WERE ADDED. THE PARTICULATE MATTER FLOATED IN THE SOLUTION. NO FLUID INSIDE THE CONTAINER SINCE IT'S AN EMPTY BAG. THE EVENT OCCURRED WHEN PREPARING AN INFUSION FOR A PATIENT. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN THERAPY. VYANZON (B)(6) 2024 UPDATE: ICU MEDICAL RECEIVED A MEDWATCH UF/IMPORTER REPORT #MW515880. ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE SUSPECT MEDICAL DEVICE HAS A COMMON DEVICE NAME OF CONTAINER, I.V.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20251449 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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