Angiodynamics recalls DURAFLOW 2 55cm Straight Basic Kit for hemodialysis access due to potential metal shavings that could cause surgical removal. Affected units have specific 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 55cm Straight Basic Kit for hemodialysis access because metal shavings inside the Tri-Ball Tunneler could travel to the bloodstream and require surgery. This risk affects 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 the bloodstream, they might require surgical removal to prevent serious complications.
Patients using hemodialysis or apheresis treatments with the DUR:AFLOW 2 kit are most at risk. The recall applies to specific lot numbers of the kit.
Check for the product name 'DURAFLOW 2 55CM STRAIGHT BASIC KIT PG' with lot number 5805171. The kit is used for long-term hemodialysis access.
Verify the product name and lot number to confirm if your kit is affected.
The recall states metal shavings could potentially embolize and require surgical removal, but the risk is low as it's not common.
Check for the product name 'DURAFLOW 2 55CM STRAIGHT BASIC KIT PG' with lot number 5805171.
The recall 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-1763-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1763-2024 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.
