ICU Medical SC121Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709040106), received between Sep 27, 2023 and Oct 9, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE¿ STOPCOCK, 2 CLAVE¿, 0.2 MICRON FILTER, ROTATING LUER. IT WAS REPORTED THAT THE FILTERS LEAKED TOTAL PARENTERAL NUTRITION (TPN) AND REQUIRED MULTIPLE CHANGES. THE EVENT OCCURRED WHILE THE PRODUCT WAS IN USE WITH A PATIENT BUT THERE WAS NO HUMAN HARM; THE CUSTOMER STATED THAT THE NURSES STAYED ON TOP OF THIS ISSUE SO THEIR PATIENTS DID NOT SUFFER AN INFECTION OR HYPOGLYCEMIA. THIS REPORT IS THREE OF THREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17899372 ↗
• MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE¿ STOPCOCK, 2 CLAVE¿, 0.2 MICRON FILTER, ROTATING LUER. IT WAS REPORTED THAT THE FILTERS LEAKED TOTAL PARENTERAL NUTRITION (TPN) AND REQUIRED MULTIPLE CHANGES. THE EVENT OCCURRED WHILE THE PRODUCT WAS IN USE WITH A PATIENT BUT THERE WAS NO HUMAN HARM; THE CUSTOMER STATED THAT THE NURSES STAYED ON TOP OF THIS ISSUE SO THEIR PATIENTS DID NOT SUFFER AN INFECTION OR HYPOGLYCEMIA. THIS REPORT IS TWO OF THREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17899317 ↗
• MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE¿ STOPCOCK, 2 CLAVE¿, 0.2 MICRON FILTER, ROTATING LUER. IT WAS REPORTED THAT THE FILTERS LEAKED TOTAL PARENTERAL NUTRITION (TPN) AND REQUIRED MULTIPLE CHANGES. THE EVENT OCCURRED WHILE THE PRODUCT WAS IN USE WITH A PATIENT BUT THERE WAS NO HUMAN HARM; THE CUSTOMER STATED THAT THE NURSES STAYED ON TOP OF THIS ISSUE SO THEIR PATIENTS DID NOT SUFFER AN INFECTION OR HYPOGLYCEMIA. THIS REPORT IS ONE OF THREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17899301 ↗
• MalfunctionSep 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE® STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON FILTER, ROTATING LUER WHERE IT WAS REPORTED THAT FILTER WAS DEFECTED ON TOTAL PARENTERAL NUTRITION LINE, THERE ARE TWO SMALL CIRCLES ON FILTER AND ONE OF THE CIRCLES WAS FOUND TO BE LEAKING. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• Z-0209-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)45729
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n

…and 173 more.