Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque markers that could affect imaging accuracy during vascular procedures. Affected units include specific lot numbers and order numbers.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Cook is recalling certain CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight. This could lead to inaccurate imaging during medical procedures, potentially affecting patient safety.
The radiopaque marker bands may be too loose on some catheters, making them difficult to see on X-rays. They may also be too tight on others, potentially causing injury to blood vessels during procedures.
Healthcare professionals using these catheters for diagnostic or interventional vascular procedures are most at risk. Patients receiving these procedures may be affected if the catheters are used incorrectly.
Check for lot numbers 9950878 or 9953506 on the catheter packaging. The product has order number G51577 and UDI codes starting with (01)00827002515772.
Look for lot numbers 9950878 or 9953506 on the catheter packaging.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 catheters or too tight on certain CXC3.4 catheters, which could affect imaging accuracy during procedures.
Lot numbers 9950878 and 9953506 are affected.
Check the lot number on the packaging. If it matches 9950878 or 9953506, contact Cook for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0590-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0590-2020 from Cook. 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.
