Lower riskMedical device recall · FDA · Published January 3, 2019
ICU Medical ChemoLock Vial Spike Recall: Burr Particulate Risk
ICU Medical recalls ChemoLock Vial Spikes (REF CL-80S) due to potential burr particulate in one lot. Affected units may pose a risk of contamination during drug transfers.
“ICU Medical ChemoLock Vial Spike Recall: Burr Particulate Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69191-icu-medical-chemolock-vial-spike-recall-burr-particulate-risk. Based on FDA recall #Z-0805-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2019%22&limit=1).
ICU Medical, Inc. voluntarily recalled icumedical ChemoLock Vial Spike, 20mm (REF CL-80S) due to a potential for burr particulate in one lot, the FDA said on Jan. 3, 2019. The recall involves 2,050 units distributed in the U.S. and internationally.
How to tell if you have it
Brand: ICU Medical
Product: icumedical ChemoLock Vial Spike, 20mm
REF: CL-80S
Lot Number: 3757712
Quantity: 2,050 units
The hazard
The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. The hazard is a potential for one lot to contain burr particulate.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include ICU Medical CADD Yellow Medication Cassette Reservoir Recall (Aug. 20, 2026), Arrow CVC Kits Recall (April 21, 2026), and Medline Blood Culture Kit Recall (Dec. 24, 2025).
How to tell if you have this one
Check for the product name 'ChemoLock Vial Spike', model REF CL-80S, and lot number 3757712. This recall applies to one specific lot of the product.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number 3757712 on the ChemoLock Vial Spike packaging.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-0805-2019 (January 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0805-2019 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.