ICU Medical recalls oncology kits with ChemoClave vial spikes that may contain plastic burr particulate from protective caps. Affected lots include 3846114, 3855564, 3902719, 3961122. Stop using immediately to avoid potential injury.
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 oncology kits that include ChemoClave vial spikes with a risk of plastic particles from protective caps. This could cause injury if particles enter the bloodstream during IV administration.
Plastic burr particulate may originate from the protective cap during assembly and could enter the bloodstream if the vial spike is used in IV administration. This poses a risk of injury if particles are introduced into the patient's circulation.
Patients receiving chemotherapy through IV lines using the recalled kits are most at risk. Healthcare providers using these kits for cytotoxic medication administration are also affected.
Check for lot numbers 3846114, 3855564, 3902719, or 3961122 on the ChemoClave vial spikes. The kits include a 12" extension set, Spiros with red cap, clamp, and graduated adapter.
Discard the recalled oncology kits with affected vial spikes to prevent potential injury from plastic particles entering the bloodstream.
Plastic burr particulate may originate from the protective cap used in assembly and could enter the bloodstream during IV administration.
Lot numbers 3846114, 3855564, 3902719, and 3961122.
Check the lot number on the ChemoClave vial spikes; affected lots include 3846114, 3855564, 3902719, and 3961122.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1094-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1094-2019 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.
