ICU Medical NC101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709036246), received between Jul 2, 2026 and Jul 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K100576); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A 7" (18 CM) PRESSURE INFUSION (350PSIG) SMALLBORE EXT SET WITH NEUTRON, PURPLE CLAMP, ROTATING LUER IT WAS REPORTED THAT HAD RECENT ISSUES WITH THE EXTENSION SET WITH NEUTRON VALVES THAT THEY USE WITH THE PICC LINES. THE EXTENSION SETS ARE REPORTED TO HAVE BEEN LEAKING AND THE ONE IN THE REPORTER OFFICE HAS BLOOD BACKED UP INTO THE EXTENSION SET. THE EVENT OCCURRED DURING TPN OR INTRALIPID THERAPY ON PATIENTS. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719258 ↗
• MalfunctionJul 2, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) PRESSURE INFUSION (350PSIG) SMALLBORE EXT SET WITH NEUTRON, PURPLE CLAMP, ROTATING LUER WITH ITEM NUMBER. IT WAS REPORTED THAT THEY HAD RECENT ISSUES WITH THE EXTENSION SET WITH NEUTRON VALVES THAT THEY USE WITH THE PICC LINES. PICC NURSES HAVE TOLD THAT 3 INCIDENCES HAVE OCCURRED IN THE LAST TWO WEEKS WITH THREE DIFFERENT PATIENTS. THE EXTENSION SETS ARE REPORTED TO HAVE BEEN LEAKING AND THE ONE IN THE REPORTER OFFICE HAS BLOOD BACKED UP INTO THE EXTENSION SET. THE EVENT OCCURRED DURING TPN OR INTRALIPID THERAPY ON PATIENTS. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM. THERE WAS NO DELAY IN THERAPY, AND THE EXTENSION SET WAS REPLACED ASEPTICALLY WITH NEW NC-101 EXTENSION SET. THE DEVICES WERE ATTACHED TO 1.4 FRENCH PICC LINES WHICH IS CONTAMINATED WITH BLOOD AND INTRALIPIDS ARE PRESENT IN THE DEVICE AND VISUALLY LIPIDS ARE PRESENT AROUND THE BLUE NEUTRON VALVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692495 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-1720-2022 · Aug 1, 2022 · Open, Classified
  8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
• Z-0204-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
• Z-0193-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
• Z-0192-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
• Z-0201-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
• Z-0197-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
• Z-1916-2020 · Oct 4, 2019 · Terminated
  REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889