Hospira 795113Recalls & reported problems
ICU Medical, Inc. · 500 mL EMPTY CONTAINER · Class 2
All models of Hospira (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887787006824), received between Nov 27, 2024 and May 9, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 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
- Contamination2
- Fluid/Blood Leak2
- Particulates2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Contamination; Particulates; Contamination; Particulates
THE EVENT WAS REPORTED VIA A MEDSUN MEDWATCH UF/IMPORTER REPORT # MW5168398 AND MW5168399 AND INVOLVED EMPTY LIFECARE CONTAINER 500 ML SIZE. THE CUSTOMER REPORTED THAT A COMPOUNDED TOTAL PARENTERAL NUTRITION (TPN) WAS BEING PREPARED USING 500ML EMPTY CONTAINERS (SINGLE USE BAGS). UPON FINAL INSPECTION OF THE COMPOUNDED PRODUCT, TWO DIFFERENT BAGS FROM THE SAME ICU MEDICAL PACKAGE HAD A SINGLE SMALL PIECE OF CLEAR PLASTIC SUSPENDED IN THE SOLUTION (MW5168398). THERE IS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS COMPLAINT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997005 ↗MalfunctionMay 8, 2025Contamination; Particulates; Contamination; Particulates
THE EVENT WAS REPORTED VIA A MEDSUN MEDWATCH UF/IMPORTER REPORT # MW5168398 AND MW5168399 AND INVOLVED EMPTY LIFECARE CONTAINER 500 ML SIZE. THE CUSTOMER REPORTED THAT A COMPOUNDED TOTAL PARENTERAL NUTRITION (TPN) WAS BEING PREPARED USING 500ML EMPTY CONTAINERS (SINGLE USE BAGS). UPON FINAL INSPECTION OF THE COMPOUNDED PRODUCT, TWO DIFFERENT BAGS FROM THE SAME ICU MEDICAL PACKAGE HAD A SINGLE SMALL PIECE OF CLEAR PLASTIC SUSPENDED IN THE SOLUTION (MW5168398). THERE IS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS COMPLAINT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988706 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED AN EMPTY LIFECARE CONTAINER 500 ML WHERE THE CUSTOMER REPORTED THAT THERE WAS A LEAK AT THE INJECTION PORT. THERE WAS NO CONTROLLED SUBSTANCE INSIDE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.
Patient problems: Insufficient Information
MAUDE report 20792674 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
AN EVENT INVOLVED AN EMPTY LIFECARE CONTAINER 500 ML WHERE THE CUSTOMER REPORTED THAT THE DEVICE HAD LOOSE PORTS THAT COULD POP OFF AND ALLOWED THE FLUID TO LEAK THROUGH. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20792154 ↗
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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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