ICU Medical CL3520Recalls & reported problems

Icu Medical, Inc. · 40" (102 cm) Appx 5.2 ml, Admin Set w/2 ChemoLock™, 20 Drop In-Line Drip Chamber, Bag Hanger · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709057036), received between Aug 2, 2017 and Dec 21, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

59 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.

Recalls naming this device

May 12, 2026Class IIOpen, Classified
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Z-3161-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Connection Problem1
Fluid/Blood Leak1
Leak/Splash1

Patient problems

No Consequences Or Impact To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 21, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT AN ADMINISTRATION SET HAD A HOLE IN THE TOP OF THE WHITE PLASTIC OF THE DRIP CHAMBER AND CHEMOTHERAPY CONTINUE TO DRIP DESPITE CLAMPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8190601 ↗
MalfunctionOct 27, 2017Leak/Splash; Leak/Splash
COMPLAINT RECEIVED REGARDING ONE CL3520, REPORT STATES: CHEMOTHERAPY WAS HUNG USING THE CHEMO LOCK SECONDARY SET (CL3520). AS SOON AS THE SECONDARY SET WAS ATTACHED TO THE CHEMO BAG IT STATED LEAKING WHERE THE TUBING ATTACHES TO THE BLUE CONNECTOR ABOVE THE DRIP CHAMBER. IT WAS A CONTINUOUS DRIP UNTIL THE NURSE DETACHED THE CL3520 FROM THE CHEMO BAG AND REPLACED IT WITH ANOTHER CL3520 AND LEAKAGE DISCONTINUED. PROPER PPE WAS UTILIZED. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6984725 ↗
MalfunctionAug 2, 2017Connection Problem; Connection Problem
LEAK NOTED BELOW THE UPPER CHEMOLOCK OF CL3520. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6762002 ↗

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, 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-0356-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
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-0352-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Z-0343-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Z-0357-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Z-0344-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Z-0362-2026 · Sep 8, 2025 · Open, Classified
ICU 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-0364-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Z-0349-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Z-0348-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Z-0353-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Z-0340-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Z-0331-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

…and 44 more.

Device details

UDI-DI	`00887709057036`
Brand	ICU Medical
Model	CL3520
Company	Icu Medical, Inc.
Product code	ONB · Closed antineoplastic and hazardous drug reconstitution and transfer system
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.

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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 · each recall links to the FDA recall notice
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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