Angiodynamics recalls BIOFLO 8F single plastic filled devices with non-valved connectors that may delay implantation procedures due to improper snap lock connections. Affected units have specific model numbers and were sold for long-term central venous access.
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Angiodynamics is recalling BIOFLO 8F single plastic filled devices with non-valved connectors because they may not connect properly during implantation, causing delays in medical procedures. This affects patients needing long-term central venous access for treatments like chemotherapy or blood products.
The snap lock connectors in these devices may not meet precise dimensional specifications. This means the catheter cannot be inserted into the connector before connecting to the port chamber, which delays the implantation procedure. The issue does not cause immediate harm but affects the timing of medical procedures.
Patients using the BIOFLO 8F device for long-term central venous access, such as those receiving chemotherapy or blood products, are most at risk. The device is typically used in medical settings with specific procedures.
Check for model numbers H965440140 or Cat. No. 44-014 on the device. The product was sold for long-term access to the central venous system for treatments like chemotherapy and blood products.
Look for model numbers H965440140 or Cat. No. 44-014 on the device.
The snap lock connectors may not meet dimensional specifications, causing the catheter to not connect properly with the port chamber during implantation procedures, which delays the implantation process.
The device may delay implantation procedures but does not cause immediate injury or harm. The risk is related to procedural timing rather than direct patient injury.
Check for model numbers H965440140 or Cat. No. 44-014 on the device. The product was sold for long-term central venous access for treatments like chemotherapy and blood products.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0501-2020 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0501-2020 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.
