Angiodynamics recalls BioFlo DuraMax 15.5F 24cm VascPak kits for possible metal shavings that could cause blockages requiring surgery.
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Angiodynamics recalls BioFlo DuraMax 15.5F 24cm VascPak kits used for long-term dialysis access. Metal shavings inside the Tri-Ball Tunneler could travel to the bloodstream and cause serious complications needing surgery.
The Tri-Ball Tunneler component may have loose metal shavings that can break off and enter the bloodstream. This could cause blockages or require surgical removal to prevent serious complications.
Patients using this kit for hemodialysis or apheresis treatments are most at risk. The product is used by medical professionals in hospitals and clinics.
Check for the product name 'BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit'. Lot number 5810278 is associated with this recall.
Verify the product name and lot number (5810278) to confirm if it's recalled.
Yes, metal shavings could enter the bloodstream and require surgery.
The recall record does not specify a remedy, so check with your healthcare provider for guidance.
Look for the product name 'BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit' and lot number 5810278.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1774-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1774-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
