ICU Medical CL4110Recalls & reported problems
Icu Medical, Inc. · 40" (102 cm) Appx 7.9 ml, Admin Set w/2 ChemoLock™ W/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Bag 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 00887709090644), received between Mar 12, 2026 and Mar 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).
60 other recalls cover devices cleared under the same FDA submission (K131549); 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
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Device Contamination with Chemical or Other Material
THE EVENT INVOLVED A 40" (102 CM) APPX 7.9 ML, ADMIN SET W/2 CHEMOLOCK® W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, 0.2 MICRON FILTER, BAG HANGER. THE CUSTOMER REPORTED THAT THEY FOUND SOME TYPE OF RESIDUE INSIDE THE TUBING JUST ABOVE THE DRIP CHAMBER. NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24596162 ↗MalfunctionMar 12, 2026Device Contamination with Chemical or Other Material
THE EVENT INVOLVED A 40" (102 CM) APPX 7.9 ML, ADMIN SET W/2 CHEMOLOCK® W/RED CAP, 20 DROP IN-LINE DRIP CHAMBER, 0.2 MICRON FILTER, BAG HANGER. THE CUSTOMER REPORTED THAT THEY FOUND SOME TYPE OF RESIDUE INSIDE THE TUBING JUST ABOVE THE DRIP CHAMBER. NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586172 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131549. One submission often covers many models, so check the product and lot details in each record.
- Z-3159-2026 · May 12, 2026 · Open, ClassifiedOncology sets with drip chambers
- Z-3161-2026 · May 12, 2026 · Open, ClassifiedIV Sets with drip chambers
- Z-2210-2026 · Mar 24, 2026 · Open, ClassifiedOncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL
- Z-0356-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
- Z-0346-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Closed Vial Spike REF: CL-80
- Z-0330-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
- Z-0350-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Port REF: CL2100
- Z-0365-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
- Z-0362-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
- Z-0345-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
- Z-0328-2026 · Sep 8, 2025 · Open, ClassifiedChemoLock Bag Spike, 01 units REF: CL-10-10
- Z-0334-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
- Z-0341-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Bag Spike REF: CL-10
- Z-0331-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
- Z-0343-2026 · Sep 8, 2025 · Open, ClassifiedICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
…and 45 more.
Other Closed antineoplastic and hazardous drug reconstitution and transfer system devices
- BD PhaSeal 515003BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall183 reports
- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- Alaris 10012241-0500BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- ICU Medical CL3011Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls26 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- ICU Medical CL3511Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls6 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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