ICU Medical 20116-01Recalls & reported problems
Icu Medical, Inc. · ChemoClave™ Vented Bag Spike · 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 00840619023256), received between Sep 3, 2024 and Sep 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Flow” (1 report).
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 Flow1
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 3, 2024No Flow; No Flow
THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE IT WAS REPORTED THERE WAS AN OCCLUSION. IT WAS STATED THERE ARE 9 INVOLVED PROBLEMATIC DEVICES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. THIS REPORT CAPTURES 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127783 ↗
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-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
- 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
Other Set, administration, intravascular devices
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- 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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