Angiodynamics recalls BIOFLO 8F port kits with potential snap lock connector issues that could delay implantation procedures. Affected units have specific model numbers and serial codes.
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 certain BIOFLO 8F port kits because the snap lock connectors might not fit properly, which could delay the implantation procedure. This affects medical devices used in port implantation surgeries.
The snap lock connectors in the recalled port kits may not meet precise dimensional specifications. This can prevent the catheter from being inserted into the connector before connecting to the port chamber, causing delays in the implantation procedure.
Patients undergoing port implantation surgery who use the recalled BIOFLO 8F port kits are most at risk. Healthcare providers using these kits for surgical procedures may also be affected.
Check for model numbers 5478033 or 5482424 on the product label. The product is identified by the serial code H965440220 and catalog number 44-022.
Look for model numbers 5478033 or 5482424 on the product label.
The snap lock connectors may not meet dimensional specifications, which can delay the implantation procedure.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected model numbers.
The recall states a potential delay in implantation procedures but does not mention injury risks.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0504-2020 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0504-2020 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.
