Angiodynamics recalls 5F DL BIOFLO PASV kits with potential unsafe bacterial endotoxins. Affected units have specific catalog and lot numbers. Consumers should contact the company for details.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics is recalling certain 5F DL BIOFLO PASV kits due to possible unsafe levels of bacterial endotoxins. This could pose a health risk if the kits are used improperly. The recall affects specific catalog and lot numbers.
The kits might contain unsafe levels of bacterial endotoxins, which are substances that can cause fever or other health issues when introduced into the body. This risk is particularly relevant for medical procedures where the kits are used directly.
Medical professionals using the 5F DL BIOFLO PASV kits for vascular procedures are most at risk. Patients receiving these kits may also be affected if the endotoxins cause an adverse reaction.
Check for the catalog number 60M141006 and lot numbers 5304286 or 5318620 on the kit packaging. The recall applies to specific units sold with these identifiers.
Reach out to Angiodynamics Inc. (Navilyst Medical Inc.) for specific instructions on how to handle the affected kits.
The kits might contain unsafe levels of bacterial endotoxins, which can cause fever or other health issues.
Units with catalog number 60M141006 and lot numbers 5304286 or 5318620.
The recall does not specify an immediate stop-use requirement; contact the manufacturer for guidance.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2207-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2207-2018 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.
