ICU Medical CL2100TRecalls & reported problems

Icu Medical, Inc. · ChemoLock™ Port · 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 00887709099296), received between Oct 29, 2023 and Oct 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (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

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

Free or Unrestricted Flow1

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.

MalfunctionOct 29, 2023Free or Unrestricted Flow; Free or Unrestricted Flow
THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ PORT WHERE IT WAS REPORTED THAT THE PRODUCT IS PULLING FROM THE PRIMARY BAG AND SECONDARY BAG AT THE SAME TIME. THE EVENT OCCURRED ON DURING INFUSION. THE PRODUCT HAS BEEN USED BEFORE THE ISSUE WAS NOTICED AND THERE WAS NO LEAKING. THERE WAS PATIENT INVOLVED, AND UNKNOWN PATIENT HARM, BUT THE ISSUE RESULTED INTO PROLONGED INFUSION TIME AND THERE WAS DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18026873 ↗

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-0345-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Z-0352-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Z-0350-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Port REF: CL2100
Z-0336-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Z-0346-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Z-0343-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Z-0342-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
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-0364-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Z-0344-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
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

…and 44 more.

Device details

UDI-DI	`00887709099296`
Brand	ICU Medical
Model	CL2100T
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): Neutral-pressure intravenous line needleless valve-connector

A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. 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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