Angiodynamics recalls DURAFLOW 2 vascular access devices due to potential metal shavings that could cause embolism requiring surgery. 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.
Angi: DURAFLOW 2 vascular access devices for hemodialysis may contain loose metal shavings that could travel to the bloodstream and require surgery. This recall affects specific model numbers and lot numbers.
The Tri-Ball Tunneler component may have loose metal shavings that could enter the bloodstream, potentially causing blockages or requiring surgical removal. This risk occurs during normal use when the device is in place.
Hemodialysis patients and healthcare providers using the DURAFLOW 2 devices for long-term vascular access are most at risk. Affected units have specific product numbers and lot numbers.
Check for product number H787103012185 and lot number 5805849 on the device. The DURAFLOW 2 24cm Straight Vasc-Pak PG is designed for hemodialysis vascular access.
Look for product number H787103012185 and lot number 5805849 on the device.
The Tri-Ball Tunneler may contain loosely affixed metal shavings that could embolize, potentially requiring surgical removal.
Check for product number H787103012185 and lot number 5805849. If you have the affected model, contact Angiodynamics for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1764-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1764-2024 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.