Angiodynamics recalls DURAFLOW 2 vascular access devices due to potential metal shavings that could cause surgical removal. Affected units have specific product numbers and lot numbers.
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Angi: DURAFLOW 2 vascular access devices for hemodialysis may contain metal shavings that could travel to the bloodstream, requiring surgery. This is a serious risk for patients needing long-term dialysis access.
The Tri-Ball Tunneler component may have loose metal shavings that can enter the bloodstream. If these shavings travel to critical areas, they might require surgical removal to prevent serious complications.
Patients using hemodialysis or apheresis treatments with the DURAFLOW 2 device are most at risk. The device is intended for long-term vascular access in these medical procedures.
Check for product number H787103012195 and lot number 5807415 on the device. The DURAFLOW 2 is a 28cm straight vascular access device used for hemodialysis and apheresis.
Immediately stop using the DURAFLOW 2 device if it has the product number H787103012195 and lot number 5807415.
The device is intended for hemodialysis and apheresis, but the recall means it may have metal shavings that could require surgery.
Stop using it immediately and contact Angiodynamics for instructions on next steps.
Look for product number H787103012195 and lot number 5807415 on the device label.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1765-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1765-2024 from Angiodynamics. 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.
