Angiodynamics recalls BIOFLO 8F ports due to snap lock connector issues that may delay implantation procedures. 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 ports because their snap lock connectors might not fit properly, which could delay the implantation procedure. This is a medical device used for long-term access to the central venous system.
The snap lock connectors in the port kits may not meet precise dimensional specifications. This means the catheter cannot be inserted into the connector before connecting to the port chamber, causing delays during implantation procedures.
Patients who have received the BIOFLO 8F port for long-term central venous access are likely affected. Healthcare providers using these ports for medical procedures are at risk of procedural delays.
Check for the model number H965440210 or catalog number 44-021 on the port device. These ports were sold for long-term access to the central venous system for administering fluids and blood products.
Look for the model number H965440210 or catalog number 44-021 on the port device.
The snap lock connectors may not meet dimensional specifications, which can delay the implantation procedure.
The risk is a delay in the implantation procedure due to the catheter not being able to insert into the snap lock connector before connecting to the port chamber.
Check for the model number H965440210 or catalog number 44-021 on the port device.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0503-2020 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0503-2020 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.