ICU Medical CH3226Recalls & reported problems
Icu Medical, Inc. · 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros™, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619025670), received between Sep 17, 2026 and Sep 17, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Fluid/Blood Leak
The event involved a 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter. The reporter stated Leakaged from Spiro (1 incident occurred.) The event occurred during infusion. There was no Concomitant Drug and no Concomitant Device. There was no Bleedback, with Chemo, no Biohazard, no User Facility MedWatch and no Device was Reprocessed/Resterilized. Sample is available for investigation. There was Patient Involvement, no Adverse Event/Patient Harm, and no Delay in Critical Therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801654 ↗
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
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- 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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