ICU Medical B33056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709006041), received between Oct 10, 2024 and Oct 10, 2024 — 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.

• MalfunctionOct 10, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE COMPLAINT/EVENT INVOLVED A 7" PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®,PURPLE CLAMP, ROTATING LUER. THE REPORTER STATED THAT, AFTER DISCONNECTING IV TUBING FROM THE BLUE OCCLUSIVE CAP AT THE END OF AN IV EXTENSION SET, THE BLUE OCCLUSIVE CAP BECAME DISLODGED BY ITSELF THAT CAUSED THE IV TO LEAK BLOOD. WHEN CHECKED, THE OCCLUSIVE CAP HAD COME FULLY DISLODGED FROM THE TUBING OF THE IV EXTENSION SET. THE RN OCCLUDED THE VEIN, HAD ANOTHER RN GRAB A SECOND SET, TWISTED OFF THE OCCLUSIVE CAP FROM THAT SET, AND USED THAT AND A FLUSH TO SEAL AND THEN FLUSH THE IV IN THE PATIENT'S ARM. IT WAS FOUND FROM STAFF IN THE ER THAT THE CAP INDICATED IN THE STATEMENT WILL SOMETIMES BE LOOSE WHEN THE ITEM IS REMOVED FROM THE PACKAGING AND MENTIONED IT WAS AS IF IT HAD NOT BEEN COMPLETELY SCREWED ONTO THE TUBE. THERE WAS NO ADVERSE EVENT AND NO DELAY IN THERAPY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20416220 ↗

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-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-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-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