ICU Medical recalls 20mm ChemoLock IV devices with potential plastic burrs from protective caps. Affected lots include specific serial numbers for CL-80S and CL-80S-10 models. Contact for remedy.
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 certain ChemoLock IV administration devices that may contain plastic burrs from protective caps. This could cause injury if the burrs enter the bloodstream during IV treatment. The recall affects specific model numbers and production lots.
Plastic burrs can form inside the protective cap during manufacturing. If these burrs enter the IV line during treatment, they could potentially cause injury by entering the bloodstream.
Healthcare professionals using the ChemoLock devices for IV treatments are most at risk. Patients receiving IV medications through these devices may be affected if the burrs enter their bloodstream.
Check for model numbers CL-80S or CL-80S-10 with specific lot numbers listed in the recall notice. The devices are used in IV administration sets for medical treatments.
Look for the lot number on the device's protective cap or label to determine if it's affected.
The hazard is that certain lots may contain plastic burrs from the protective cap, which could enter the bloodstream during IV treatment.
Affected models are CL-80S and CL-80S-10 with specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact ICU Medical directly 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-1096-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1096-2019 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.
