ICU Medical CL4176Recalls & reported problems

Icu Medical, Inc. · 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock™ Port, Clamp, ChemoLock™ w/Red Cap · 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-0340-2026 · 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-3159-2026 · May 12, 2026 · Open, Classified
Oncology sets with drip chambers
Z-3161-2026 · May 12, 2026 · Open, Classified
IV 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-0359-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Z-0341-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Bag Spike REF: CL-10
Z-0357-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Z-0354-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
Z-0336-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Z-0345-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Z-0363-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Z-0329-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Z-0356-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Z-0333-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
Z-0328-2026 · Sep 8, 2025 · Open, Classified
ChemoLock Bag Spike, 01 units REF: CL-10-10
Z-0346-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Closed Vial Spike REF: CL-80

…and 44 more.

Device details

UDI-DI	`00887709123359`
Brand	ICU Medical
Model	CL4176
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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