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.
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.
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.
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.
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.
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.
Identify the lot numbers on your ChemoLock spike to see if they match the recalled list.
The recall is due to potential plastic burr particulate from the protective cap that could enter the bloodstream during IV use.
9 units: 4 of model CL-80S-4 and 5 of model CL-80S-5.
Check the lot numbers against the list provided. If you have a recalled lot, stop using it and contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1097-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1097-2019 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
