ICU Medical B33213Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709006836), received between May 14, 2025 and May 14, 2025 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED ON AN UNKNOWN DATE INVOLVING A 7" (18 CM) APPX 0.31ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®, PURPLE CLAMP, ROTATING LUER, NON-DEHP TUBING WHERE IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING/BREAKING IN PEDIATRIC INTENSIVE CARE UNIT (PICU) HUB. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021589 ↗

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-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-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-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