ICU Medical CL-72Recalls & reported problems

Icu Medical, Inc. · ChemoLock™ Vented Vial Spike, 13mm · Class 2

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

2 open recalls name 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: 2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709062443), received between Jan 15, 2025 and Jan 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

58 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-0345-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Jun 27, 2022Class IIOpen, Classified
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Z-1681-2022 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Device problems

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.

MalfunctionJan 15, 2025Material Separation; Material Separation
THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED TWO CHEMOLOCK¿ VENTED VIAL SPIKES, 13MM. THE CUSTOMER REPORTED THAT THE TIPS ON THE SYRINGES DISCONNECTED ON THESE DEVICES. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THE EVENT/COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21161361 ↗

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-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-0349-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
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-0347-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Z-0357-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Z-0332-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Z-0341-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Bag Spike REF: CL-10
Z-0354-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
Z-0348-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Z-0356-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Z-0346-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
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

…and 43 more.

Device details

UDI-DI	`00887709062443`
Brand	ICU Medical
Model	CL-72
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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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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