Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque marker bands that could affect imaging during vascular procedures. Affected units include specific model numbers and lot 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 the radiopaque marker bands to be too loose or too tight. This could affect imaging accuracy during vascular procedures.
The radiopaque marker bands may be too loose or too tight on specific catheter models. This could lead to inaccurate imaging during vascular procedures, potentially affecting treatment decisions.
Healthcare professionals using these catheters for vascular procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model number RPN CXC3.4-2.2-18-90-P-NS-0 and order number G51575. Lot number 9945303 and UDI (01)00827002515758(17)221308(10)9945303 are also identifiers.
Verify the model number, order number, lot number, and UDI to confirm if your catheter is affected.
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, potentially affecting imaging accuracy during vascular procedures.
The recall record does not specify a remedy, so check the product details to confirm if your catheter is affected.
Look for the model number RPN CXC3.4-2.2-18-90-P-NS-0, order number G51575, lot number 9945303, and UDI (01)00827002515758(17)221308(10)9945303.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0588-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0588-2020 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.
