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ICU Medical B3361Recalls & reported problems

Icu Medical, Inc. · 7" (18 cm) Appx 0.72 ml, Pressure Infusion (400psig) Ext Set w/MicroClave®, Purple Clamp, Rotating Luer · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709008410), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (1 report).

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

Device problems

  • Material Discolored1
  • Particulates1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 6, 2022Material Discolored; Particulates; Material Discolored; Particulates

    THE EVENT INVOLVED A 7" (18 CM) APPX 0.7 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED GUNK IN THE END OF THE CONNECTOR WHEN OPENING THE TUBING PACKAGE. IT WAS ALSO REPORTED THAT THE TUBING WAS DISCOLORED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, NO HARM REPORTED AND NO DELAY IN THERAPY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15362313 ↗

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-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-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-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

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

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