ICU Medical recalls central venous catheters due to guidewire not passing through needles. This may cause complications during medical procedures. Affected models include 50456-01 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 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 do not allow the guidewire to pass through properly. This can cause difficulties during insertion or maintenance of the catheter, potentially leading to complications like infections or improper placement.
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 504:56-01 and lot numbers starting with 4350491/0 0840619 03011 7. These catheters were sold for hemodynamic monitoring in medical settings.
Verify the model number is 50456-01 and lot numbers match the specified identifiers.
Reach out to ICU Medical directly for guidance on next steps if you have the recalled catheters.
The catheter kits include needles that prevent the guidewire from passing through, which can cause complications during medical procedures.
Check the model number and lot numbers to confirm if it's affected. Contact ICU Medical for further instructions.
The recall is due to potential complications during procedures, but the remedy does not specify immediate stop-use or serious injury risk.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2002-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2002-2020 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.
