Angiodynamics recalls Bio-Stable 5F SL-... kits with potential bacterial endotoxins. Affected kits may cause fever or infection. Contact for return instructions.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics recalls certain medical kits that might contain unsafe levels of bacterial endotoxins. This could lead to fever or infection if used in medical procedures.
The kits might contain unsafe levels of bacterial endotoxins, which are substances that can cause fever or infection when introduced into the body during medical procedures.
Healthcare professionals using the Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG (Catalog Number 45-892) are most at risk. Patients receiving procedures with these kits may also be affected.
Check for the catalog number 45-892 on the kit packaging. The product was sold under UPN H965458920 and lot number 5304323.
Look for the catalog number 45-892 on the kit packaging to confirm if it is affected.
The recall states that the kits might contain unsafe levels of bacterial endotoxins, so they should not be used until the manufacturer provides instructions.
Check for the catalog number 45-892 on the kit packaging. The product was sold under UPN H965458920 and lot number 5304323.
The recall does not specify a remedy, so contact Angiodynamics for instructions on how to handle the product.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2195-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2195-2018 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.
