ICU Medical ChemoLock Spike Recall: Plastic Particles Risk
ICU Medical recalls 9 units of ChemoLock Closed Vial Spikes with potential plastic burr particulate from protective caps. Stop using if you have specific lot numbers listed.
Lower-risk recall
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.
Contact the company
What happened, in plain English
ICU Medical is recalling 9 units of ChemoLock Closed Vial Spikes used in IV administration. These products may contain plastic burr particulate from the protective cap, which could enter the bloodstream during IV use. Read more at govinfonow.com/recall/68959-icu-medical-chemolock-spike-recall-plastic-particles-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/68959-icu-medical-chemolock-spike-recall-plastic-particles-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1097-2019
Cite this page
“ICU Medical ChemoLock Spike Recall: Plastic Particles Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68959-icu-medical-chemolock-spike-recall-plastic-particles-risk. Based on FDA recall #Z-1097-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2019%22&limit=1).
Why it’s dangerous
The protective cap used in manufacturing may release small plastic particles. These particles could enter the bloodstream during IV administration, potentially causing an adverse reaction.
Who’s affected
Healthcare professionals using IV administration sets with the recalled ChemoLock spikes. Patients receiving IV treatments with these spikes are at risk if particles enter the bloodstream.
How to tell if you have this one
Check for model numbers CL-80S-4 (4 units) or CL-80S-5 (5 units). Look for specific lot numbers: 3820520, 3820521, 3844785 for CL-80S-4 and 3820516, 3820523, 3839238, 3839239, 3844781, 3844782, 3853998, 3853999, 3866769, 3866770, 3872090, 3910645, 3932908, 3932910, 3946770, 3951236 for CL-80S-5.
- Brand
ICU Medical- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1092-2019 | 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 hazardous drugs.; Lot Numbers: 3866759, 3872252, 3910046, 3910627 | 27200 devices |
| Z-1093-2019 | 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 hazardous drugs.; Lot Numbers: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512 | 60500 devices |
| Z-1094-2019 | 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 administration of cytotoxic medications.; Lot Numbers: 3846114, 3855564, 3902719, 3961122 | 18150 devices |
| Z-1095-2019 | 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 administration of cytotoxic medications.; Lot Numbers: 3846116, 3855565 | 300 devices |
| Z-1096-2019 | 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 medications for healthcare personnel.; (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 | 160775 devices |
| Z-1097-2019 | 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 exposure to cytotoxic medications for healthcare personnel.; (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 | 23800 devices |
| Z-1098-2019 | 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 hazardous drugs.; Lot Numbers: 3872008, 3899761 | 3500 units |
What to do — step by step
Check Product Lot Numbers
Identify the lot numbers on your ChemoLock spike to see if they match the recalled list.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1097-2019 (February 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1097-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.