Angiodynamics recalls RS TANDEM 5F DL BIOFLO PASV kits due to potential unsafe bacterial endotoxins. Affected kits may cause fever or infection if used improperly.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics is recalling certain RS TANDEM 5F DL BIOF: PASV kits because they might contain unsafe levels of bacterial endotoxins. This could lead to fever or infection if the kits are used.
The kits might contain unsafe levels of bacterial endotoxins, which are substances that can cause fever or infection when introduced into the body. This risk is specific to medical use and not typical in normal consumer settings.
Patients using the RS TANDEM 5F DL BIOFLO PASV kits for medical procedures are likely affected. Those with compromised immune systems may be at higher risk.
Check for the catalog number 60M120196 on the kit packaging. The product was sold with UPN H96560M1201961 and lot number 5314930.
Look for the catalog number 60M120196 on the kit packaging to confirm if it is affected.
The kits might contain unsafe levels of bacterial endotoxins, which can cause fever or infection if used.
Check for the catalog number 60M120196 on the kit packaging. The product was sold with UPN H96560M1201961 and lot number 5314930.
The recall record does not specify a remedy, so contact Angiodynamics for further instructions.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2204-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2204-2018 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.
