ICU Medical CL3511TRecalls & reported problems

Icu Medical, Inc. · 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, ChemoLock™ w/Red Cap, Bag Hanger · 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

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 ↗

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-0344-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Z-0347-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Z-0356-2026 · Sep 8, 2025 · Open, Classified
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
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-0361-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Z-0343-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Z-0351-2026 · Sep 8, 2025 · Open, Classified
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Z-0341-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock Bag Spike REF: CL-10
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-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-0355-2026 · Sep 8, 2025 · Open, Classified
ICU Medical ChemoLock w/Mini Bag Spike REF: C-17

…and 44 more.

Device details

UDI-DI	`00887709120013`
Brand	ICU Medical
Model	CL3511T
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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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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