Angiodynamics recalls DURAFLOW 2 vascular access kits due to potential metal shavings that could cause surgical removal. Affected kits 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.
Angiodynamics is recalling DURAF: 2 vascular access kits because metal shavings inside the Tri-Ball Tunneler could travel to the bloodstream and require surgery. This is serious but not immediate for most users.
The Tri-Ball Tunneler component may have loose metal shavings that can enter the bloodstream. If these shavings travel to the bloodstream, they could cause blockages or require surgical removal.
Hemodialysis and apheresis patients using the DURAFLOW 2 kits with specific product numbers and lot numbers are most at risk. Others using these kits for long-term vascular access may also be affected.
Check for product number H787103012021 and lot numbers 5805837 on the kit packaging. The DURAFLOW 2 28cm Straight Basic Kit is designed for hemodialysis and apheresis procedures.
Look for product number H787103012021 and lot number 5805837 on the kit packaging.
The Tri-Ball Tunneler may contain loosely affixed metal shavings that could embolize and require surgical removal.
Check the product number and lot number on the packaging. If it matches, contact Angiodynamics for instructions.
The product is not safe if it contains metal shavings that could travel to the bloodstream, but the risk is not immediate for all users.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1761-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1761-2024 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.