ICU Medical CH3401Recalls & reported problems
Icu Medical, Inc. · 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave™ Drip Chamber, 0.2 Micron Filter, Spiros™, Hanger · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619068363), received between Sep 27, 2019 and Sep 27, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K070532); 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
Device problems
- Fluid/Blood Leak2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ETOPOSIDE WAS FOUND TO LEAK INSIDE DOUBLE CHEMO BAGS. IT WAS REPORTED THAT THE CLEAR PLASTIC PIECE IN THE CENTER GETS PUSHED IN WHEN THEY ADD DRUGS VIA THE CONNECTOR AND DID NOT POP BACK OUT TO CLOSE THE VALVE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9130415 ↗MalfunctionSep 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CISPLATIN WAS FOUND TO LEAK INSIDE DOUBLE CHEMO BAGS. IT WAS REPORTED THAT THE CLEAR PLASTIC PIECE IN THE CENTER GETS PUSHED IN WHEN THEY ADD DRUGS VIA THE CONNECTOR AND DID NOT POP BACK OUT TO CLOSE THE VALVE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9130414 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2021 · Aug 31, 2020 · Open, Classified42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE
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.
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