Angiodynamics recalls DURAFLOW 2 32cm Straight Basic Kit for hemodialysis access 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.
Angiodynamics is recalling its DURAFLOW 2 3:2cm Straight Basic Kit for hemodialysis access because metal shavings inside the Tri-Ball Tunneler could become loose and travel to the bloodstream, requiring surgery to remove. This risk is serious for patients with long-term dialysis access.
The Tri-Ball Tunneler component may have metal shavings that can become loose and enter the bloodstream. If these shavings travel to the bloodstream, they could cause blockages or require surgical removal to prevent serious complications.
Patients using the DURAFLOW 2 kit for long-term hemodialysis access are most at risk. The product is used by individuals with kidney failure requiring regular dialysis treatments.
Check for product number H787103012035 and lot number 5805839 on the kit. The DURAFLOW 2 kit is used for long-term hemodialysis access and is sold for patients needing regular dialysis treatments.
Look for product number H787103012035 and lot number 5805839 on the kit.
Yes, the Tri-Ball Tunneler may contain metal shavings that could become loose and travel to the bloodstream, requiring surgical removal.
Check for product number H787103012035 and lot number 5805839 on the kit.
The recall record does not specify a remedy, so contact Angiodynamics directly for guidance.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1762-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1762-2024 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.