ICU Medical recalls ChemoClave Vial Spikes (lot 3872008, 3899761) due to potential plastic burrs from protective caps. These burrs could cause contamination during IV use.
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 Vial Spikes with specific lot numbers because they may contain plastic burrs from the protective cap. This could lead to contamination during IV administration, posing a risk to patients and healthcare workers.
The protective cap used in manufacturing may release small plastic particles (burr particulate) into the vial spike. These particles could contaminate the IV solution during use, potentially exposing patients and healthcare workers to harmful substances.
Healthcare workers and patients using the ChemoClave Vial Spikes with lot numbers 3872008 or 3899761 for IV administration sets are most at risk.
Check the lot number on the ChemoClave Vial Spike packaging. Affected lots are 3872008 and 3899761. These spikes are used in IV administration sets for medication delivery.
Look for lot numbers 3872008 or 3899761 on the ChemoClave Vial Spike packaging.
The protective cap used in manufacturing may release small plastic particles (burr particulate) that could contaminate the IV solution during use.
Lot numbers 3872008 and 3899761.
The recall does not specify a stop-use instruction; you can continue using them if you check the lot number.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1098-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1098-2019 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.
