Angiodynamics recalls RS TANDEM 5F DL BIOFLO PASV kits with potential bacterial endotoxins. Affected units have specific catalog and lot numbers. Consumers should contact for details.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics is recalling certain RS TANDEM 5F DL BIOFLO PASV kits due to possible unsafe levels of bacterial endotoxins. This could cause fever or infection if used improperly. Affected units have specific catalog and lot numbers.
The kits might contain unsafe levels of bacterial endotoxins (pyrogens), which can cause fever or infection in some users. This risk is typically low but could be serious for sensitive individuals or during medical procedures.
Medical professionals using the RS TANDEM 5F DL BIOFLO PASV kits for procedures are most at risk. Patients receiving these kits may also be affected if the endotoxins cause an adverse reaction.
Check for catalog number 60M232242 and lot numbers 5304324 or 5316020 on the kit packaging. The product was sold with UPN H96560M2322421.
Look for catalog number 60M232242 and lot numbers 5304324 or 5316020 on the kit packaging.
The recall is for potential bacterial endotoxins that could cause fever or infection, but the risk is low. The manufacturer does not specify a need to stop using immediately.
Contact Angiodynamics directly for details on your specific product and instructions.
Check for catalog number 60M232242 and lot numbers 5304324 or 5316020 on the kit packaging.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2215-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2215-2018 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.