ICU Medical CL-33Recalls & reported problems

Icu Medical, Inc. · Double ChemoLock™ Port Syringe Transfer Set · 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: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

Sep 8, 2025Class IIOpen, Classified
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0342-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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-0337-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Z-0331-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Z-0339-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Z-0350-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Port REF: CL2100
Z-0353-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Z-0355-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
Z-0347-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Z-0364-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
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
Z-0328-2026 · Sep 8, 2025 · Open, Classified
ChemoLock Bag Spike, 01 units REF: CL-10-10
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

…and 44 more.

Device details

UDI-DI	`00840619061722`
Brand	ICU Medical
Model	CL-33
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	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 4, 2021

Device type (GMDN): Medication transfer set

A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

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All Closed antineoplastic and hazardous drug reconstitution and transfer system 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
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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