ICU Medical 011-MC33001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619057442), received between Jan 14, 2025 and Jan 14, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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.

• MalfunctionJan 14, 2025Difficult to Open or Close; No Flow; Difficult to Open or Close; No Flow

  IT WAS REPORTED THAT AN 18 CM (7") APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER, WAS FOUND TO BE OCCLUDED DURING PATIENT USE. IT WAS STATED THAT THE EXTENSION HAD A PURPLE CLAMP THAT MADE IT DIFFICULT TO ATTACH AFTER WASHING. IT WAS INFORMED THAT AT THE HOSPITAL THEY HAVE A POST-INFUSION WASHING PROTOCOL, WITH THE RIGHT HAND THEY CONNECT A SYRINGE WITH SALINE SOLUTION AND PERFORM THE PUSH/STOP TECHNIQUE. AT THE SAME TIME, WITH YOUR LEFT HAND, CLAMP THE EXTENSION TUBE AND THEN DISCONNECT THE SALINE SYRINGE. THE CUSTOMER REPORTS THAT THE PURPLE LARGE SLIDE CLAMP IS VERY HARD AND MAKES IT DIFFICULT TO HOLD CORRECTLY WITH ONE HAND. THEY BELIEVE THE EXTENSIONS MAY BE POORLY SECURED AND HAVE DETECTED AN INCREASE IN AIRWAY OCCLUSION. IT WAS ALSO REPORTED THAT THE PROBLEM DID NOT ONLY HAPPEN WITH THIS BATCH, BUT THEY ALSO DETECTED OTHER TIMES THAT THE CLAMP WAS VERY HARD. THERE WAS A NON-USED SISTER SAMPLE AVAILABLE FOR EVALUATION. ACCORDING TO THE FORM, THE PRODUCT IS NOT CONTAMINATED, DOES NOT PRESENT A BIOLOGICAL RISK OR CONTAINS A CHEMOTHERAPEUTIC AGENT. THE PRODUCT WAS USED WITH AN UNSPECIFIED MEDICATION AND HAD NOT BEEN REPROCESSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153820 ↗

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-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-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-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