Angiodynamics recalls DURAMAX Stacked Tip kits for possible metal shavings that could cause embolism requiring surgery. Affected kits sold in 2023 with lot number 5807204.
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 DURAMAX Stacked Tip kits that may contain metal shavings. These shavings could travel to the bloodstream and require surgical removal, posing a serious health risk for patients needing long-term vascular access.
The Tri-Ball Tunneler component may have loose metal shavings that can enter the bloodstream. If these shavings travel to critical areas, they could cause blockages requiring surgical removal.
Patients using hemodialysis or apheresis treatments with the recalled DURAMAX Stacked Tip kits are most at risk. The kits were sold in 2:2023 with lot number 5807204.
Check for the product name 'DURAMAX Stacked Tip 28cm STR. BASIC KIT, 5-UP PG' with lot number 5807204. These kits were sold in 2023 for hemodialysis and apheresis treatments.
Immediately stop using the DURAMAX Stacked Tip kit if you have the recalled lot number 5807204.
The Tri-Ball Tunneler may contain metal shavings that could travel to the bloodstream and require surgical removal.
Check for the product name 'DURAMAX Stacked Tip 28cm STR. BASIC KIT, 5-UP PG' with lot number 5807204.
Immediately stop using the kit and contact Angiodynamics for further instructions.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1769-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1769-2024 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.