ICU Medical CL4151Recalls & reported problems

Icu Medical, Inc. · 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 · 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: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709098381), received between May 30, 2025 and May 30, 2025 — classified as 1 malfunction.

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

Reports received per month

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

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-0338-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Fluid/Blood Leak1

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.

MalfunctionMay 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE COMPLAINT INVOLVED A 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. IT WAS STATED IN THE REPORT THAT A PATIENT EXPERIENCED A SMALL LEAK OF 5FU WHILE ON CADD PUMP WITH CADD KIT (CL4151). CUSTOMER SAYS THAT IT LOOKS LIKE THE LEAK IS HAPPENING AT THE Y-SITE WITH CHEMOLOCK PORT. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY. IN ADDITION TO THE ABOVE ENTRY, THE CUSTOMER BECAME AWARE OF THE ISSUE WHEN THE NURSE NOTICED WHITE POWDER SUBSTANCE ON PUMP CARRYING POUCH WHEN PATIENT RETURNED FOR DISCONNECT. THE DEVICE WAS USED FOR 2 DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22117606 ↗

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-0354-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
Z-0364-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Z-0328-2026 · Sep 8, 2025 · Open, Classified
ChemoLock Bag Spike, 01 units REF: CL-10-10
Z-0334-2026 · Sep 8, 2025 · Open, Classified
ICU 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-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-0363-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Z-0365-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Z-0331-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Z-0336-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Z-0343-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
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-0349-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

…and 44 more.

Device details

UDI-DI	`00887709098381`
Brand	ICU Medical
Model	CL4151
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 · 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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