Lower riskMedical device recall · FDA · Published November 6, 2024
ICU Medical ChemoLock Close Vial Spike REF CL-80 Recall: Incorrect Packaging and Labeling
ICU Medical recalls ChemoLock Close Vial Spike REF CL-:80 due to incorrect packaging and labeling. This may cause confusion in healthcare settings. Affected units have specific lot numbers and model details.
“ICU Medical ChemoLock Close Vial Spike REF CL-80 Recall: Incorrect Packaging and Labeling.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53549-icu-medical-chemolock-close-vial-spike-ref-cl-80-recall. Based on FDA recall #Z-0652-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0652-2025%22&limit=1).
ICU Medical, Inc. recalled ChemoLock Close Vial Spike REF CL-80 units due to incorrect packaging and labeling, the FDA said on Nov. 6, 2024. The recall affects 6,000 units distributed in Illinois, Canada, and nationwide.
How to tell if you have it
ChemoLock Close Vial Spike REF CL-80
UPC 10887709057125
Lot Number 13959938
The hazard
The ChemoLock Closed System Transfer Device was recalled because finished goods were incorrectly packaged and labeled. The device is designed to prevent environmental contaminant transfer and needlestick injuries.
Context
GovInfoNow's records show ICU Medical, Inc. has had 60 other recalls on record since June 15, 2017. Recent brand recalls include the Aug. 20, 2026, CADD Yellow Medication Cassette Reservoir Recall and the June 24, 2026, Hotline Fluid Warming Set Recall. Other recent recalls of similar products include the Oct. 17, 2025, Mozarc Medical Acute High Pressure Catheter Tray Recall and the June 12, 2026, Medline Convenience Kits Recall.
How to tell if you have this one
Check for the model number CL-80 on the device. Affected units have the lot number 13959938 and UDI code (01)10887709057125(17)290401(30)50(10)13959938.
Brand
ICU Medical
Product
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Labeling
Look for the model number CL-80 and lot number 13959938 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.” 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 published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0652-2025 (November 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0652-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.