ICU Medical recalls ChemoClave Vial Spikes (lot numbers 3866759, 3872252, 3910046, 3910627) due to potential plastic burr particulate from protective caps. These spikes are used in IV administration sets for safe drug handling.
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 lots of ChemoClave Vial Spikes used in IV administration sets because they may contain plastic burrs from the protective cap. This could pose a risk of injury if the burrs enter the bloodstream during use.
The protective cap used in manufacturing may release small plastic burrs. If these burrs enter the bloodstream during IV use, they could cause injury. However, the hazard is not described as causing serious injury in normal use.
Healthcare workers and patients using IV administration sets with the recalled ChemoClave Vial Spikes (lot numbers 3866759, 3872252, 3910046, 3910627) are most at risk.
Check the lot number on the ChemoClave Vial Spike packaging. The recalled lots are 3866759, 3872252, 3910046, and 3910627. These spikes are used in IV administration sets for needle-free drug delivery.
Look for the lot number on the ChemoClave Vial Spike packaging to determine if it is one of the recalled lots: 3866759, 3872252, 3910046, or 3910627.
The protective cap used in manufacturing may release small plastic burrs that could enter the bloodstream during IV use.
The affected lot numbers are 3866759, 3872252, 3910046, and 3910627.
Check the lot number on the packaging. If it matches the recalled lots, you should stop using it and contact ICU Medical 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-1092-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1092-2019 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.
