ICU Medical CH3554Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709076013), received between Sep 11, 2023 and Sep 11, 2023 — classified as 2 malfunctions.

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

7 other recalls cover devices cleared under the same FDA submission (K081361); 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.

• MalfunctionSep 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 CLAMPS, VENTED CAP WHERE IT WAS REPORTED THAT THE BURETTE WAS LEAKING FROM THE BOTTOM. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS NORMAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720448 ↗
• MalfunctionSep 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 CLAMPS, VENTED CAP WHERE IT WAS REPORTED THAT THE BURETTE WAS LEAKING FROM THE BOTTOM. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS NORMAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720447 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081361. 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-3158-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1565-2021 · Mar 16, 2021 · Open, Classified
  REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medicatio
• Z-1566-2021 · Mar 16, 2021 · Open, Classified
  REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications
• Z-0701-2021 · Aug 31, 2020 · Open, Classified
  5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (1
• Z-1092-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanica
• Z-1093-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanical