Hospira 795112Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10887787006855), received between Dec 3, 2019 and Feb 20, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Particulates” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50422) 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 24408026 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50623) 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 24408024 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH: 50944) 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 24406028 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50831) 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 24402727 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50402) 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 24402705 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 49968) 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 24402281 ↗
• MalfunctionFeb 19, 2026Particulates

  AN COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50481) 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 24394147 ↗
• MalfunctionFeb 19, 2026Particulates

  AN COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 49742) 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 24394016 ↗
• MalfunctionFeb 19, 2026Particulates

  AN COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 49015) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. AN EMAIL WITH INTERACTION NUMBER (B)(4) RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE WITH LIST NUMBER 079510470 AND LOT NUMBER 14035783. IT WAS STATED IN THE REPORT THAT THE FENTANYL BATCH 48995 49015 49742 AND 50481 HAVE BEEN SEEN FOR PARTICULATE MATTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394010 ↗
• MalfunctionFeb 19, 2026Particulates

  AN COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 48995) 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 24394006 ↗
• MalfunctionFeb 19, 2026Particulates

  AN EMAIL WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR MIDAZOLAM (BATCH 49085) 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 24391109 ↗
• MalfunctionFeb 19, 2026Particulates

  AN EMAIL WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 49506) 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 24390743 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING AN EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 49304) 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 24389512 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING AN 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 24389497 ↗
• MalfunctionJun 4, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A SEMPTY LIFECARE CONTAINER 250 ML SIZE THAT REPORTEDLY LEAKED AN UNSPECIFIED LIQUID BECAUSE THE OPEN JOINTS WERE NOT CONNECTED TO THE BAG. THERE WAS NO HUMAN HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144489 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING AN EMPTY LIFECARE CONTAINER 250 ML SIZE THAT EXPERIENCED LEAKAGE. IT WAS STATED IN THE REPORT THAT THE PCA BAG IS A BAG THAT HOLDS LIQUIDS, AND THE OPEN CONNECTOR IS NOT ATTACHED TO THE BAG, WHICH RESULTED IN A LIQUID LEAKAGE. THE EVENT OCCURRED ON 18-APR-2025. PATIENT INVOLVEMENT AND PATIENT ADVERSE EVENT ARE UNKNOWN. THERE IS ONE QUANTITY AFFECTED AND ONE SAMPLE IS RETURNING FOR INVESTIGATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039918 ↗
• MalfunctionApr 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A COMPLAINT WAS RECEIVED REGARDING A EMPTY LIFECARE CONTAINER 250 ML SIZE THAT EXPERIENCED PARTICULATE MATTER IN THE FLUID PATH. 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 PICTURE AND VIDEO PROVIDED SHOWING THE INSTANCES OF PARTICLES FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939750 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED AN EMPTY LIFECARE CONTAINER 100 ML SIZE THAT REPORTEDLY LEAKED AN UNSPECIFIED FLUID FROM THE SIDE AND THAT THE TOP OF THE DEVICE/BAG WAS ALSO NOT SEALED WELL. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878511 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A EMPTY LIFECARE CONTAINER 250 ML SIZE WHERE IT WAS REPORTED THE EMPTY BAG HAS LEAKAGE. THE SET WAS USED WITH ERBITUX. THERE WERE OBVIOUS DEFECTS NOTED ON THE TUBING SET LIKE CRACK. THERE WAS NO SPILLAGE OR ANY DRUG EXPOSURE TO PATIENT OR STAFF. THE TUBING WAS REPLACED AND THERAPY RESUMED. THE PRODUCT WAS STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL AND WAS NOT EXPOSED IN EXTREME TEMPERATURE CONDITION. SAMPLE VIDEO OF THE EMPTY CONTAINER CONNECTED TO AN IV SET WHERE FLUIDS WERE LEAKING FROM THE RUBBER CONNECTOR WHERE THE SPIKE WAS CONNECTED IS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210824 ↗
• MalfunctionDec 3, 2019Particulates; Particulates

  THE EVENT INVOLVED AN EMPTY LIFECARE 250 ML CONTAINER THAT THE CUSTOMER REPORTED DURING PREPARATION THE OFFICER NOTICED THE PRESENCE OF A CONTAMINANT INSIDE THE BAG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9402688 ↗