ICU Medical, Inc.: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

Agency Publication Date: April 15, 2019

Affected Products

Product: icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to h

Lot Numbers: 3866759, 3872252, 3910046, 3910627

Lot Numbers:

Numbers

Product: icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to ha

Lot Numbers: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512

Lot Numbers:

Numbers

Product: icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administrati

Lot Numbers: 3846114, 3855564, 3902719, 3961122

Lot Numbers:

Numbers

Product: icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient admin

Lot Numbers: 3846116, 3855565

Lot Numbers:

Numbers

Product: icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medicatio

(a) REF CL,-80S, Lot numbers: 3824204, 3824209, 3826652, 3828646, 3829557, 3836196, 3836811, 3853995, 3853997, 3866764, 3866766, 3872065, 3872072, 3872085, 3872093, 3872433, 3872444, 3910642, 3920773, 3932270, 3945868, 3946776 (b) REF CL-80S-10 (10 units), Lot Numbers: 3820519, 3820522, 3839240, 3839241, 3844783, 3844784, 3854004, 3854005, 3910656, 3932907, 3946771, 3946772

Lot Numbers:

numbers

Numbers

Product: icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the

(a) REF CL-80S-4, Lot Numbers: 3820520, 3820521, 3844785 (b) REF CL-80S-5, Lot Numbers: 3820516, 3820523, 3839238, 3839239, 3844781, 3844782, 3853998, 3853999, 3866769, 3866770, 3872090, 3910645, 3932908, 3932910, 3946770, 3951236

Lot Numbers:

Numbers

Product: SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazar

Lot Numbers: 3872008, 3899761

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82291

Status: Resolved

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 7 products (27200 devices; 60500 devices; 18150 devices; 300 devices; 160775 devices; 23800 devices; 3500 units)

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 · FDA Press Release · 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.

Affected Products

Lot Numbers: 3866759, 3872252, 3910046, 3910627

Lot Numbers:

Numbers

Lot Numbers: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512

Lot Numbers:

Numbers

Lot Numbers: 3846114, 3855564, 3902719, 3961122

Lot Numbers:

Numbers

Lot Numbers: 3846116, 3855565

Lot Numbers:

Numbers

Lot Numbers:

numbers

Numbers

Lot Numbers:

Numbers

Lot Numbers: 3872008, 3899761

Lot Numbers:

Numbers