ICU Medical CH3943Recalls & reported problems
Icu Medical, Inc. · Oncology Kit w/12" Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm; Spiros™ w/Red Cap · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709082632), received between Sep 9, 2026 and Sep 16, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “No Flow” (6 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.
Reports received per month
Most reported problems
Device problems
- No Flow6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026No Flow
The event involved a Oncology Kit, 12 IN Ext, 2 Spiros, Graduated Adapter, 2 ChemoClave Vial Spike 1 13mm 1 20mm. It was reported that BCG tubing being defective and she changed the tubing and it worked fine also add it occurred during DOS. When administering the BCG, the blue connector that they are supposed to connect to the foley catheter was stuck inward, which would not allow medicine to flow to gravity. There was a patient involvement and no reported harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789922 ↗MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698420 ↗MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698203 ↗MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697845 ↗MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696526 ↗MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696116 ↗
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-3158-2026 · May 12, 2026 · Open, ClassifiedOncology sets with drip chambers
- Z-3160-2026 · May 12, 2026 · Open, ClassifiedIV Sets with drip chambers
- Z-1566-2021 · Mar 16, 2021 · Open, ClassifiedREF 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-1565-2021 · Mar 16, 2021 · Open, ClassifiedREF 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-0701-2021 · Aug 31, 2020 · Open, Classified5 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 · Terminatedicumedical 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 · Terminatedicumedical 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
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page