Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
icumedical ChemoLock Recalled by ICU Medical, Inc. Due to There is a potential for certain lots of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected Products
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.
Quantity: 160775 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report