ICU Medical recalls ChemoClave Vial Spikes with potential plastic burr particulate from protective caps. Affected lots include 3826647-3952512. Stop using if you have these items.
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 ChemoClave Vented Vial Spikes that may contain plastic burr particulate from the protective cap. This could cause harm if particles enter the bloodstream during IV administration. Affected lots are listed in the recall notice.
The protective cap used in manufacturing may contain plastic burr particulate that can enter the bloodstream during IV administration. This could cause harm if particles are introduced into the patient's body through the IV line.
Healthcare professionals using IV administration sets with the recalled ChemoClave Vial Spikes are most at risk. Patients receiving IV treatments with these spikes could potentially be exposed to plastic particles.
Check the lot numbers on your ChemoClave Vial Spike packaging: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512.
Identify if your ChemoClave Vial Spike has a lot number in the list: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512.
The protective cap used in manufacturing may contain plastic burr particulate that could enter the bloodstream during IV administration.
Lot numbers 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512.
The recall does not require immediate stop use; check the lot numbers to determine if your item is affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1093-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1093-2019 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.
