ICU Medical recalls central venous catheters due to guidewire not passing through needles, which may cause complications during use. Affected models include 41401-25 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 needles are designed to allow guidewires to pass through for proper placement. When the guidewire cannot pass through the needles, it may cause improper placement or complications during medical procedures.
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.
Check for model number 414:01-25 and lot numbers starting with UDI-4156005/1 0840619 04410 4. These catheters were sold for hemodynamic monitoring in medical settings.
Look for model number 41401-25 and lot numbers starting with UDI-4156005/1 0840619 04410 4 on the catheter packaging.
The catheter needles may not allow the guidewire to pass through, which could lead to improper placement and complications during medical procedures.
The official recall notice does not specify a remedy, so contact ICU Medical directly for guidance.
The recall indicates a potential for complications during use, but the official notice does not specify a risk of serious injury.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1998-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1998-2020 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.
