ICU Medical recalls central venous catheters due to guidewire not passing through needles, which may cause complications during use. Affected models include 41411-25 with specific lot numbers.
Inability for the guidewire to pass through the needles included with the catheter kits.
ICU Medical is recalling central venous catheters because the guidewire often cannot pass through the needles included with the kits. This could lead to complications during medical procedures if the catheter is used improperly.
The catheter kits include needles that may not allow the guidewire to pass through properly. This can cause the catheter to become stuck or misaligned during insertion, potentially leading to complications like bleeding or infection.
Healthcare professionals who use these catheters for hemodynamic monitoring are most at risk. Patients receiving the catheters may also be affected if the issue causes complications during procedures.
Check for model number 414:11-25 on the catheter packaging. Lot numbers starting with UDI-4192314 or 10840619046450 are affected. These catheters were sold for hemodynamic monitoring in medical settings.
Look for model number 41411-25 on the catheter packaging or label.
Reach out to ICU Medical directly for further assistance if you have the affected model.
The recall is happening because the guidewire often cannot pass through the needles included with the catheter kits, which may cause complications during medical procedures.
The official notice does not specify a remedy, so contact ICU Medical directly for further assistance.
Yes, affected lot numbers include UDI-4192314 and 10840619046450.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2000-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2000-2020 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.
