ICU Medical recalls oncology kits with potential plastic burr particles in vial spikes. Affected lots include 3846116 and 38555: stop using immediately to avoid 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 may contain plastic burr particles in the vial spikes. This could cause injury if particles enter the bloodstream during IV administration.
Plastic burr particles may be present in the vial spikes, which are used to connect chemotherapy vials to IV lines. If particles enter the bloodstream during IV administration, they could cause injury.
Patients receiving chemotherapy through IV using these kits are at risk. Healthcare providers using the affected lots must stop use immediately.
Check for lot numbers 3846116 or 3855565 on the vial spikes. The kit includes ChemoClave Vented Vial Spike, 20mm and 13mm models.
Discard the affected vial spikes and kit components to prevent potential injury from plastic particles entering the bloodstream.
Plastic burr particles may be present in the vial spikes, which could enter the bloodstream during IV administration.
Lot numbers 3846116 and 3855565.
Check the lot numbers on the vial spikes; affected lots are 3846116 and 3855565.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1095-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1095-2019 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.
