ICU Medical CH3556Recalls & reported problems
Icu Medical, Inc. · 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave™, Spiros™, Clamp · 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 00887709076341), received between Nov 19, 2020 and Nov 19, 2020 — 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.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORTER # (B)(4) WAS RECEIVED WHICH STATED THE FOLLOWING: ¿PATIENT RECEIVING IV HYDRATION WITH STANDARD IV 3 PORT TUBING AND CHEMO FILTER. RN PUT TOGETHER TUBING SET FOR UPCOMING CHEMOTHERAPY INFUSION. ONCE CONNECTED, THE SPIROS FILTER LINE WAS LEAKING AT THE SPIROS CAP (18¿ EXT SET W/0.2 MICRON FILTER CLAVE, SPIROS, CLAMP). AFTER THIS WAS DISCOVERED, REPLACED IV TUBING WITH NEW LINE SET UP.¿ IT WAS ALSO REPORTED THAT THE ORIGINAL INTENDED PROCEDURE WAS CHEMOTHERAPY INFUSION AND THAT THE DEVICE FAILED (E.G BROKE, COULDN¿T GET IT TO WORK OR STOPPED WORKING), THE EVENT HAPPENED AT HOSPITAL IN THE PATIENT¿S ROOM AND THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY. THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2020.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10871757 ↗
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
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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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