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Lifeshield 0269428Recalls & reported problems

ICU Medical, Inc. · Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lock (previously Hospira product) · Class 2

All models of Lifeshield (34)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787005018), received between Aug 9, 2022 and Aug 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

Most reported problems

Device problems

  • Fluid/Blood Leak3

Patient problems

  • Chemical Exposure3
  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE ONCOLOGY UNIT HAS EXPERIENCED LEAKING FROM THEIR 0.2-MICRON FILTER TUBING. IT WAS INDICATED THAT IT WAS SPECIFICALLY LEAKING FROM THE FILTER. THEIR CURRENT PRACTICE IS CHANGING THE TUBING/FILTER AFTER DAY 2 OF ADMINISTRATION. THERE WERE NO ISSUES NOTED DURING THE INITIAL PRIMING/SET-UP OF THE SET. IT IS UNKNOWN IF THE CHEMOTHERAPY BEING USED CAME IN CONTACT WITH THE PATIENT BUT UNFORTUNATELY, SOME CHEMO WAS WASTED BECAUSE OF THE LEAKS. SHE CONFIRMED THAT THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS NO HARM TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15191269 ↗
  • MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE ONCOLOGY UNIT HAS EXPERIENCED LEAKING FROM THEIR 0.2-MICRON FILTER TUBING. IT WAS INDICATED THAT IT WAS SPECIFICALLY LEAKING FROM THE FILTER. THEIR CURRENT PRACTICE IS CHANGING THE TUBING/FILTER AFTER DAY 2 OF ADMINISTRATION. THERE WERE NO ISSUES NOTED DURING THE INITIAL PRIMING/SET-UP OF THE SET. IT IS UNKNOWN IF THE CHEMOTHERAPY BEING USED CAME IN CONTACT WITH THE PATIENT BUT UNFORTUNATELY, SOME CHEMO WAS WASTED BECAUSE OF THE LEAKS. SHE CONFIRMED THAT THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS NO HARM TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15191267 ↗
  • MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE ONCOLOGY UNIT HAS EXPERIENCED LEAKING FROM THEIR 0.2-MICRON FILTER TUBING. IT WAS INDICATED THAT IT WAS SPECIFICALLY LEAKING FROM THE FILTER. THEIR CURRENT PRACTICE IS CHANGING THE TUBING/FILTER AFTER DAY 2 OF ADMINISTRATION. THERE WERE NO ISSUES NOTED DURING THE INITIAL PRIMING/SET-UP OF THE SET. IT IS UNKNOWN IF THE CHEMOTHERAPY BEING USED CAME IN CONTACT WITH THE PATIENT BUT UNFORTUNATELY, SOME CHEMO WAS WASTED BECAUSE OF THE LEAKS. SHE CONFIRMED THAT THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS NO HARM TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15191264 ↗

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

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