ICU Medical ChemoLock and ChemosafeLock Devices Recalled for Potential Leaks

Agency Publication Date: October 27, 2025

Summary

ICU Medical, Inc. is recalling approximately 789,239 drug transfer and administration devices sold under the ChemoLock and ChemosafeLock brands. These products include bag spikes, vial spikes, and extension sets used to prepare and deliver medications. The recall was issued because the port weld on the device may separate or break during use. This can result in a medication leak, which is especially concerning when handling hazardous drugs like chemotherapy.

Risk

A broken or separated port weld can cause hazardous medications to leak from the device. This poses a risk of chemical exposure to healthcare workers and may lead to inadequate delivery of the prescribed dose to the patient.

What You Should Do

This recall affects over 780,000 drug transfer devices including ChemoLock Bag Spikes, Vented Vial Spikes, Extension Sets, and Administration Sets, as well as ChemosafeLock adapters and connectors.
Identify if you have these products by checking the REF (catalog number) and Lot number on the device label or packaging. Affected catalog numbers include CL-10-10, CL-70-10, CL2100-NS, CL2150, CL3011, CL3511, CL3929, CL3940, CL4136, CL4138, CL4151, CL4173, CL4176, CL-10, CL-33, CL-70, CL-70S, CL-72, CL-80, CL-80S, CL-80S-5, CL-82, CL2100, CL3360, CL3900, CL3955, 011-CL-70S-20, C-17, CL-34, CL-35, CL-3950, CL3951, CL3967, CL4118, CL4188, KL-BS001U3, KL-FNU3, and KL-VA001U3 through KL-VA321U3.
See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately and sequester them to prevent accidental use.
Contact ICU Medical, Inc. or your specific distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ChemoLock Bag Spike, 01 units

Model / REF:

CL-10-10

Lot Numbers:

14397202

UDI:

10887709071022

Recall #: Z-0328-2026

Product: ChemoLock Universal Vented Vial Spike

Model / REF:

CL-70-10

Lot Numbers:

14380109

UDI:

00887709070981

Recall #: Z-0329-2026

Product: ChemoLock Port, Bulk, Non-Sterile

Model / REF:

CL2100-NS

Lot Numbers:

14407400

UDI:

00887709094505

Recall #: Z-0330-2026

Product: Clave Bag Spike w/ChemoLock Port

Model / REF:

CL2150

Lot Numbers:

14391937

UDI:

10887709094670

Recall #: Z-0331-2026

Product: 30" (76 cm) Admin Set w/20 Drop Integrated ChemoLock Drip Chamber

Variants: Spiros, Hanger, Drop-In Red Cap

Model / REF:

CL3011

Lot Numbers:

14386054

UDI:

10887709057019

Recall #: Z-0332-2026; Approx 3.3 mL

Product: 30" (76 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber

Variants: ChemoLock w/Red Cap, Bag Hanger

Model / REF:

CL3511

Lot Numbers:

14400616

UDI:

10887709057026

Recall #: Z-0333-2026; Approx 3.6 ml

Product: Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber

Variants: Spiros, ChemoLock Universal Vented Vial Spike, Bag Hanger

Model / REF:

CL3929

Lot Numbers:

14400216

14416769

UDI:

10887709076768

Recall #: Z-0334-2026

Product: ChemoLock Bag Spike with Clave Additive Port

Model / REF:

CL3940

Lot Numbers:

14406773

UDI:

10887709095295

Recall #: Z-0335-2026

Product: Oncology Kit w/ChemoLock, ChemoLock Port

Model / REF:

CL4136

Lot Numbers:

14393176

UDI:

10887709096131

Recall #: Z-0336-2026

Product: Oncology Transfer Kit w/ChemoClave and ChemoLock Port

Variants: Spiros w/Red Cap

Model / REF:

CL4138

Lot Numbers:

14393176

UDI:

10887709096131

Recall #: Z-0337-2026

Product: 45" (114 cm) Smallbore Ext Set w/Spiros w/Red Cap

Variants: Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer

Model / REF:

CL4151

Lot Numbers:

14400230

UDI:

10887709098388

Recall #: Z-0338-2026; Approx 1.7 ml

Product: 60" (152 cm) Ext Set, Smallbore w/ChemoLock Port

Variants: Clamp, Spiros w/Red Cap

Model / REF:

CL4173

Lot Numbers:

14351926

UDI:

10887709123080

Recall #: Z-0339-2026; Appx 1.2 ml

Product: 73" (185 cm) Ext Set, Smallbore w/ChemoLock Port

Variants: Clamp, ChemoLock w/Red Cap

Model / REF:

CL4176

Lot Numbers:

14332784

UDI:

10887709123356

Recall #: Z-0340-2026; Appx 2.5 ml

Product: ChemoLock Bag Spike

Model / REF:

CL-10

Lot Numbers:

14419330

UDI:

10887709056968

Recall #: Z-0341-2026

Product: Double ChemoLock Port Syringe Transfer Set

Model / REF:

CL-33

Lot Numbers:

14393155

14400613

14376051

UDI:

10840619061729

Recall #: Z-0342-2026

Product: ChemoLock Universal Vented Vial Spike

Model / REF:

CL-70

Lot Numbers:

14391971

14395289

UDI:

10887709057095

Recall #: Z-0343-2026

Product: ChemoLock Vented Vial Spike, 20mm

Model / REF:

CL-70S

Lot Numbers:

14379176

UDI:

10887709067155

Recall #: Z-0344-2026

Product: ChemoLock Vented Vial Spike, 13mm

Model / REF:

CL-72

Lot Numbers:

14385352

14401250

UDI:

10887709062440

Recall #: Z-0345-2026

Product: ChemoLock Closed Vial Spike

Model / REF:

CL-80

Lot Numbers:

14391976

UDI:

10887709057125

Recall #: Z-0346-2026

Product: ChemoLock Vial Spike, 20mm

Model / REF:

CL-80S

Lot Numbers:

14379182

14391979

14395300

14401254

14380121

UDI:

10887709069593

Recall #: Z-0347-2026

Product: ChemoLock Closed Vial Spike w/Skirt, 5 Units

Model / REF:

CL-80S-5

Lot Numbers:

14395313

14393195

14396054

UDI:

10887709077116

Recall #: Z-0348-2026

Product: ChemoLock 13mm Closed Vial Spike

Model / REF:

CL-82

Lot Numbers:

14407453

UDI:

10887709085692

Recall #: Z-0349-2026

Product: ChemoLock Port

Model / REF:

CL2100

Lot Numbers:

14400191

14379145

UDI:

10887709057002

Recall #: Z-0350-2026

Product: 21" Ext Set w/ChemoLock Port

Variants: Clamp, Graduated Connector

Model / REF:

CL3360

Lot Numbers:

14397348

14377757

UDI:

10887709071398

Recall #: Z-0351-2026

Product: Graduated Connector w/ChemoLock Port

Model / REF:

CL3900

Lot Numbers:

14391954

UDI:

10887709071411

Recall #: Z-0352-2026

Product: 6.5" Bag Spike w/ChemoLock Port Additive Port

Variants: ChemoLock Port

Model / REF:

CL3955

Lot Numbers:

14386086

14407433

UDI:

10887709071411

Recall #: Z-0353-2026

Product: ChemoLock Vented Vial Spike, 20mm, 20 Units

Model / REF:

011-CL-70S-20

Lot Numbers:

14401659

Recall #: Z-0354-2026; Distributed in France

Product: ChemoLock w/Mini Bag Spike

Model / REF:

C-17

Lot Numbers:

14385224

Recall #: Z-0355-2026; Distributed in Canada

Product: Syringe Transfer Set w/MicroClave, ChemoLock Port

Model / REF:

CL-34

Lot Numbers:

14400199

Recall #: Z-0356-2026; Distributed in Canada

Product: ChemoLock Port w/Spiros, Red Cap

Model / REF:

CL-35

Lot Numbers:

14407070

14384996

14391949

Recall #: Z-0357-2026; Distributed in Canada

Product: 8" (20 cm) Ext Set w/MicroClave Clear

Variants: ChemoLock Port, Y-Connector, Rotating Luer

Model / REF:

CL-3950

Lot Numbers:

14393168

14414091

Recall #: Z-0358-2026; Distributed in Canada

Product: 31" (79 cm) Admin Set w/20 Drop Integrated ChemoLock Drip Chamber

Variants: Spiros, Purple Cap, Hanger

Model / REF:

CL3951

Lot Numbers:

14397353

14418912

Recall #: Z-0359-2026; Distributed in Canada; Appx 3.4 ml

Product: 7.5" (19 cm) Ext Set w/ChemoLock Port

Variants: Clamp, Graduated Adapter

Model / REF:

CL3967

Lot Numbers:

14369083

14386090

14391965

Recall #: Z-0360-2026; Distributed in Canada; Appx 1.5 ml

Product: 6" (15 cm) Ext Set w/MicroClave Clear

Variants: ChemoLock Port, Y-Connector, Rotating Luer

Model / REF:

CL4118

Lot Numbers:

14393173

14409213

Recall #: Z-0361-2026; Distributed in Canada

Product: Oncology Kit w/ChemoLock Bag Spike and Ext Set

Variants: 13mm Closed Vial Spike

Model / REF:

CL4188

Lot Numbers:

14369087

Recall #: Z-0362-2026; Distributed in Canada

Product: ChemosafeLock Bag Spike

Model / REF:

KL-BS001U3

Lot Numbers:

14399518

14399521

14406408

14399520

14406410

14406411

Recall #: Z-0363-2026; Distributed in Japan

Product: ChemosafeLock Connecter

Model / REF:

KL-FNU3

Lot Numbers:

14399518

14399521

14406408

14399520

14406410

14406411

Recall #: Z-0364-2026; Distributed in Japan

Product: ChemosafeLock Vial Adapter

Model / REF:

KL-VA001U3

KL-VA002U3

KL-VA131U3

KL-VA201U3

KL-VA202U3

KL-VA321U3

Lot Numbers:

14360690

14345871

14367719

14381368

14381367

14345872

14381373

14337455

14381355

14381358

14367718

14345878

Recall #: Z-0365-2026; Distributed in Japan

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97583

Status: Active

Manufacturer: ICU Medical, Inc.

Sold By: Medical distributors; Hospitals; Oncology centers

Manufactured In: United States

Units Affected: 38 products (875 units; 2100 units; 2000 units; 200 units; 11000 units; 7950 units; 1100 units; 3000 units; 150 units; 600 units; 950 units; 200 units; 200 units; 7850 units; 4000 units; 16850 units; 11200 units; 9004 units; 6150 units; 53,050 units; 8475 units; 3350 units; 133,255 units; 950 units; 1700 units; 6450 units; 80 units; 400 units; 900 units; 2000 units; 2450 units; 11000 units; 5700 units; 1600 units; 200 units; 134700 units; 134,700 units; 202900 units)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects over 780,000 drug transfer devices including ChemoLock Bag Spikes, Vented Vial Spikes, Extension Sets, and Administration Sets, as well as ChemosafeLock adapters and connectors.

Identify if you have these products by checking the REF (catalog number) and Lot number on the device label or packaging. Affected catalog numbers include CL-10-10, CL-70-10, CL2100-NS, CL2150, CL3011, CL3511, CL3929, CL3940, CL4136, CL4138, CL4151, CL4173, CL4176, CL-10, CL-33, CL-70, CL-70S, CL-72, CL-80, CL-80S, CL-80S-5, CL-82, CL2100, CL3360, CL3900, CL3955, 011-CL-70S-20, C-17, CL-34, CL-35, CL-3950, CL3951, CL3967, CL4118, CL4188, KL-BS001U3, KL-FNU3, and KL-VA001U3 through KL-VA321U3.

See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately and sequester them to prevent accidental use.

Contact ICU Medical, Inc. or your specific distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

Affected Products

Product: ChemoLock Bag Spike, 01 units

Model / REF:

CL-10-10

Lot Numbers:

14397202

UDI:

10887709071022

Recall #: Z-0328-2026

Product: ChemoLock Universal Vented Vial Spike

Model / REF:

CL-70-10

Lot Numbers:

14380109

UDI:

00887709070981

Recall #: Z-0329-2026

Product: ChemoLock Port, Bulk, Non-Sterile

Model / REF:

CL2100-NS

Lot Numbers:

14407400

UDI:

00887709094505

Recall #: Z-0330-2026

Product: Clave Bag Spike w/ChemoLock Port

Model / REF:

CL2150

Lot Numbers:

14391937

UDI:

10887709094670

Recall #: Z-0331-2026

Product: 30" (76 cm) Admin Set w/20 Drop Integrated ChemoLock Drip Chamber

Variants: Spiros, Hanger, Drop-In Red Cap

Model / REF:

CL3011

Lot Numbers:

14386054

UDI:

10887709057019

Recall #: Z-0332-2026; Approx 3.3 mL

Product: 30" (76 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber

Variants: ChemoLock w/Red Cap, Bag Hanger

Model / REF:

CL3511

Lot Numbers:

14400616

UDI:

10887709057026

Recall #: Z-0333-2026; Approx 3.6 ml

Product: Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber

Variants: Spiros, ChemoLock Universal Vented Vial Spike, Bag Hanger

Model / REF:

CL3929

Lot Numbers:

14400216

14416769

UDI:

10887709076768

Recall #: Z-0334-2026

Product: ChemoLock Bag Spike with Clave Additive Port

Model / REF:

CL3940

Lot Numbers:

14406773

UDI:

10887709095295

Recall #: Z-0335-2026

Product: Oncology Kit w/ChemoLock, ChemoLock Port

Model / REF:

CL4136

Lot Numbers:

14393176

UDI:

10887709096131

Recall #: Z-0336-2026

Product: Oncology Transfer Kit w/ChemoClave and ChemoLock Port

Variants: Spiros w/Red Cap

Model / REF:

CL4138

Lot Numbers:

14393176

UDI:

10887709096131

Recall #: Z-0337-2026

Product: 45" (114 cm) Smallbore Ext Set w/Spiros w/Red Cap

Variants: Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer

Model / REF:

CL4151

Lot Numbers:

14400230

UDI:

10887709098388

Recall #: Z-0338-2026; Approx 1.7 ml

Product: 60" (152 cm) Ext Set, Smallbore w/ChemoLock Port

Variants: Clamp, Spiros w/Red Cap

Model / REF:

CL4173

Lot Numbers:

14351926

UDI:

10887709123080

Recall #: Z-0339-2026; Appx 1.2 ml

Product: 73" (185 cm) Ext Set, Smallbore w/ChemoLock Port

Variants: Clamp, ChemoLock w/Red Cap

Model / REF:

CL4176

Lot Numbers:

14332784

UDI:

10887709123356

Recall #: Z-0340-2026; Appx 2.5 ml

Product: ChemoLock Bag Spike

Model / REF:

CL-10

Lot Numbers:

14419330

UDI:

10887709056968

Recall #: Z-0341-2026

Product: Double ChemoLock Port Syringe Transfer Set

Model / REF:

CL-33

Lot Numbers:

14393155

14400613

14376051

UDI:

10840619061729

Recall #: Z-0342-2026

Product: ChemoLock Universal Vented Vial Spike

Model / REF:

CL-70

Lot Numbers:

14391971

14395289

UDI:

10887709057095

Recall #: Z-0343-2026

Product: ChemoLock Vented Vial Spike, 20mm

Model / REF:

CL-70S

Lot Numbers:

14379176

UDI:

10887709067155

Recall #: Z-0344-2026

Product: ChemoLock Vented Vial Spike, 13mm

Model / REF:

CL-72

Lot Numbers:

14385352

14401250

UDI:

10887709062440

Recall #: Z-0345-2026

Product: ChemoLock Closed Vial Spike

Model / REF:

CL-80

Lot Numbers:

14391976

UDI:

10887709057125

Recall #: Z-0346-2026

Product: ChemoLock Vial Spike, 20mm

Model / REF:

CL-80S

Lot Numbers:

14379182

14391979

14395300

14401254

14380121

UDI:

10887709069593

Recall #: Z-0347-2026

Product: ChemoLock Closed Vial Spike w/Skirt, 5 Units

Model / REF:

CL-80S-5

Lot Numbers:

14395313

14393195

14396054

UDI:

10887709077116

Recall #: Z-0348-2026

Product: ChemoLock 13mm Closed Vial Spike

Model / REF:

CL-82

Lot Numbers:

14407453

UDI:

10887709085692

Recall #: Z-0349-2026

Product: ChemoLock Port

Model / REF:

CL2100

Lot Numbers:

14400191

14379145

UDI:

10887709057002

Recall #: Z-0350-2026

Product: 21" Ext Set w/ChemoLock Port

Variants: Clamp, Graduated Connector

Model / REF:

CL3360

Lot Numbers:

14397348

14377757

UDI:

10887709071398

Recall #: Z-0351-2026

Product: Graduated Connector w/ChemoLock Port

Model / REF:

CL3900

Lot Numbers:

14391954

UDI:

10887709071411

Recall #: Z-0352-2026

Product: 6.5" Bag Spike w/ChemoLock Port Additive Port

Variants: ChemoLock Port

Model / REF:

CL3955

Lot Numbers:

14386086

14407433

UDI:

10887709071411

Recall #: Z-0353-2026

Product: ChemoLock Vented Vial Spike, 20mm, 20 Units

Model / REF:

011-CL-70S-20

Lot Numbers:

14401659

Recall #: Z-0354-2026; Distributed in France

Product: ChemoLock w/Mini Bag Spike

Model / REF:

C-17

Lot Numbers:

14385224

Recall #: Z-0355-2026; Distributed in Canada

Product: Syringe Transfer Set w/MicroClave, ChemoLock Port

Model / REF:

CL-34

Lot Numbers:

14400199

Recall #: Z-0356-2026; Distributed in Canada

Product: ChemoLock Port w/Spiros, Red Cap

Model / REF:

CL-35

Lot Numbers:

14407070

14384996

14391949

Recall #: Z-0357-2026; Distributed in Canada

Product: 8" (20 cm) Ext Set w/MicroClave Clear

Variants: ChemoLock Port, Y-Connector, Rotating Luer

Model / REF:

CL-3950

Lot Numbers:

14393168

14414091

Recall #: Z-0358-2026; Distributed in Canada

Product: 31" (79 cm) Admin Set w/20 Drop Integrated ChemoLock Drip Chamber

Variants: Spiros, Purple Cap, Hanger

Model / REF:

CL3951

Lot Numbers:

14397353

14418912

Recall #: Z-0359-2026; Distributed in Canada; Appx 3.4 ml

Product: 7.5" (19 cm) Ext Set w/ChemoLock Port

Variants: Clamp, Graduated Adapter

Model / REF:

CL3967

Lot Numbers:

14369083

14386090

14391965

Recall #: Z-0360-2026; Distributed in Canada; Appx 1.5 ml

Product: 6" (15 cm) Ext Set w/MicroClave Clear

Variants: ChemoLock Port, Y-Connector, Rotating Luer

Model / REF:

CL4118

Lot Numbers:

14393173

14409213

Recall #: Z-0361-2026; Distributed in Canada

Product: Oncology Kit w/ChemoLock Bag Spike and Ext Set

Variants: 13mm Closed Vial Spike

Model / REF:

CL4188

Lot Numbers:

14369087

Recall #: Z-0362-2026; Distributed in Canada

Product: ChemosafeLock Bag Spike

Model / REF:

KL-BS001U3

Lot Numbers:

14399518

14399521

14406408

14399520

14406410

14406411

Recall #: Z-0363-2026; Distributed in Japan

Product: ChemosafeLock Connecter

Model / REF:

KL-FNU3

Lot Numbers:

14399518

14399521

14406408

14399520

14406410

14406411

Recall #: Z-0364-2026; Distributed in Japan

Product: ChemosafeLock Vial Adapter

Model / REF:

KL-VA001U3

KL-VA002U3

KL-VA131U3

KL-VA201U3

KL-VA202U3

KL-VA321U3

Lot Numbers:

14360690

14345871

14367719

14381368

14381367

14345872

14381373

14337455

14381355

14381358

14367718

14345878

Recall #: Z-0365-2026; Distributed in Japan

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97583

Status: Active

Manufacturer: ICU Medical, Inc.

Sold By: Medical distributors; Hospitals; Oncology centers

Manufactured In: United States