Lifeshield 1423028Recalls & reported problems
ICU Medical, Inc. · Secondary Set, Secure Lock, 34 Inch with IV Set Hanger · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical Lifeshield secondary IV administration set is a tubing set with a drip chamber and IV hanger. Most of the 50 reports describe black specks or discoloration found inside the drip chamber or tubing, sometimes noticed when the set was removed from its package, along with a few fluid leaks and disconnections. There are no deaths and 1 injury. One open recall, started in May 2026, covers the same black specks, traced to discolored PVC material left in the drip chamber wall during plastic molding.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10887787006268), received between Dec 27, 2016 and Sep 9, 2026 — classified as 1 injury, 47 malfunctions.
The most frequently reported specific device problem is “Particulates” (21 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 12, 2026Open, Classified
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Z-3160-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Particulates21
- Fluid/Blood Leak11
- Contamination7
- Material Puncture/Hole3
- Device Contamination with Chemical or Other Material2
- Break1
- Device Operates Differently Than Expected1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Chemical Exposure2
- Chills1
- Headache1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Palpitations1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699650 ↗MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566628 ↗MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566061 ↗MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565821 ↗MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565581 ↗MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564898 ↗MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564533 ↗MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563950 ↗MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563340 ↗MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562179 ↗MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562065 ↗MalfunctionJun 17, 2026Contamination
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH, AND IT WAS REPORTED THAT BLACK SPEC WAS FOUND IN THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25530982 ↗MalfunctionJun 15, 2026Contamination
AN EVENT OCCURRED ON AN UNSPECIFIED EVENT DATE INVOLVING A SECONDARY SET REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS WERE FOUND INSIDE THE DRIP CHAMBER, ALSO IN THE AREA WHERE THE DRIP CHAMBER WAS NARROWED INTO THE TUBING AS WELL AS THE SMALLER CHAMBER JUST ABOVE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25500277 ↗MalfunctionJun 15, 2026Contamination
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH, AND IT WAS REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS WERE FOUND INSIDE THE DRIP CHAMBER. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25499132 ↗MalfunctionJun 12, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH. IT WAS REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS WERE FOUND INSIDE THE DRIP CHAMBER, ALSO IN THE AREA WHERE THE DRIP CHAMBER WERE NARROWED INTO THE TUBING. CURRENTLY, THE PATIENT INVOLVEMENT AND HARM WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492512 ↗MalfunctionJun 10, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, 34 INCH, NON-DEHP WITH INFUSION STAND HANGER THAT THE BLACK SPECKS IN DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460361 ↗MalfunctionJun 9, 2026Contamination
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, 34 INCH, NON-DEHP WITH INFUSION STAND HANGER, AND IT WAS REPORTED THAT MOBILE AND IMMOBILE DEBRIS FLOATING IN THE DRIP CHAMBER OF THE INTRAVENOUS TUBING AFTER SPIKING A NORMAL SALINE BAG WAS FOUND. THE SPECK COULD NOT BE REMOVED FROM THE PLASTIC INNER SURFACE OF THE DRIP CHAMBER EVEN WITH AGGRESSIVE SCRAPING USING A SCALPEL. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441044 ↗MalfunctionJun 9, 2026Contamination
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH, AND IT WAS REPORTED THAT THERE ARE SOME BLACK SPOTS AND DEBRIS FOUND IN THE DRIP CHAMBER UPON OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441010 ↗MalfunctionJun 9, 2026Contamination
THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH, AND IT WAS REPORTED THAT THERE ARE SOME BLACK SPOTS AND DEBRIS FOUND IN THE DRIP CHAMBER UPON OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441009 ↗MalfunctionJun 8, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT THERE ARE SOME BLACK SPOTS AND DEBRIS FOUND IN THE DRIP CHAMBER. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436640 ↗MalfunctionJun 8, 2026Particulates
AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER (34 INCH). BLACK SPOTS AND DEBRIS WERE FOUND IN THE DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25432738 ↗MalfunctionJun 5, 2026Particulates
THE INCIDENT WAS REPORTED BY (B)(6). THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411583 ↗MalfunctionJun 5, 2026Contamination
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCHES, AND IT WAS REPORTED THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25406618 ↗MalfunctionMay 25, 2026Fluid/Blood Leak
AN EVENT INVOLVING A SECONDARY SET, THERE WAS AN ISSUE WITH THE SECONDARY TUBING SETS, IT LOOKS LIKE THEY WERE LEAKING THROUGH THE VENT MULTIPLE TIMES WITH DIFFERENT SETS. THERE WERE NO REPORTED INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25271890 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
AN EVENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH REPORT STATED THAT THE SECONDARY LINE WAS LEAKING FROM THE VENT. THE PATIENT WAS ON IMMUNOTHERAPY WITH ZOLBETUXIMAB. NURSE NOTICED THE WET ON HER HAND. IT WAS FEW DROPS. NURSE WASHED HER HAND WITH SOAP AND WATER. THE TUBING WAS THEN CHANGED BY PHARMACY UNDER THE HOOD. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED
Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions
MAUDE report 24265151 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.