Angiodynamics recalls BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit with bacterial endotoxins. Affected kits may cause fever or infection during medical procedures.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics is recalling BioFlo Midline 5F DL-2:20cm Max Sterile Barrier Drape Kits due to potential unsafe levels of bacterial endotoxins. This could cause fever or infection during medical procedures if the kit is used improperly.
The drape kits might contain unsafe levels of bacterial endotoxins (pyrogens). These substances can cause fever or infection in medical settings when used during procedures. The risk is typically low but could be serious for immunocompromised patients.
Healthcare professionals using the BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit for medical procedures are most at risk. Patients receiving the kit could also be affected if the endotoxins cause an infection.
Check for the catalog number 46-490 on the kit. The kits were sold with UPN H965464901 and lots 5302405, 5312036, or 5314940.
Look for the catalog number 46-490 and UPN H965464901 on the kit packaging.
The recall is for potential unsafe levels of bacterial endotoxins, which could cause fever or infection during medical procedures. The risk is low but should be addressed.
Check for the catalog number 46-490 and UPN H965464901 on the kit packaging. The kits were sold with lots 5302405, 5312036, or 5314940.
The recall does not specify a remedy, so contact Angiodynamics for guidance on next steps.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2198-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2198-2018 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.
