ICU Medical CL2000SCPRecalls & reported problems

Icu Medical, Inc. · ChemoLock™ w/Clave® · 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 00887709069978), received between Aug 15, 2024 and Aug 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1
Material Separation1

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.

MalfunctionAug 15, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE EVENT INVOLVED A CHEMOLOCK¿ W/CLAVE¿ WHERE IT WAS REPORTED WHILE MAKING A HAZARDOUS CHEMOTHERAPY, THE CHEMOCLAVE FELL APART RESULTING IN DRUG LOSS AND SPILLAGE. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT OR STAFF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990567 ↗

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-3161-2026 · May 12, 2026 · Open, Classified
IV Sets with drip chambers
Z-3159-2026 · May 12, 2026 · Open, Classified
Oncology sets with drip chambers
Z-2210-2026 · Mar 24, 2026 · Open, Classified
Oncology 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-0345-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Z-0357-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Z-0358-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Z-0341-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Bag Spike REF: CL-10
Z-0352-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Z-0328-2026 · Sep 8, 2025 · Open, Classified
ChemoLock Bag Spike, 01 units REF: CL-10-10
Z-0330-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Z-0338-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Z-0329-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Z-0349-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Z-0331-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Z-0360-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

…and 45 more.

Device details

UDI-DI	`00887709069978`
Brand	ICU Medical
Model	CL2000SCP
Company	Icu Medical, Inc.
Product code	FPA · Set, administration, intravascular
Class	Class 2
FDA submission	K131549
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 7, 2021

Device type (GMDN): Basic intravenous administration set, noninvasive

A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Other Set, administration, intravascular devices

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1 death16,105 reports
Autosoft90™ 1002817
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1 recall11,907 reports
Minimed™ Quick-set™ MMT-399A
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9 deaths8,669 reports
Medtronic Extended MMT-431A
Unomedical A/S · Set, Administration, Intravascular
3 deaths8,574 reports
MiniMed™ Mio™ Advance MMT-242A
Unomedical A/S · Set, Administration, Intravascular
15 deaths8,164 reports
CADD 21-7302-24
Icu Medical, Inc. · Set, administration, intravascular
4 recalls1 death4,657 reports
Autosoft XC 1001681
Unomedical A/S · Set, Administration, Intravascular
1 death4,216 reports
Minimed™ Quick-set™ MMT-397A
Unomedical A/S · Set, Administration, Intravascular
19 deaths4,134 reports

All Set, administration, intravascular devices →

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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