Angiodynamics recalls Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG (Catalog 45-882) due to potential unsafe bacterial endotoxins. Affected units may pose health risks.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics recalls certain Bio-Stable 5F SL-55CM IR-145 kits because they might contain unsafe levels of bacterial endotoxins. This could lead to health issues if used improperly.
The kits might contain unsafe levels of bacterial endotoxins, which are substances that can cause fever and other health issues when introduced into the body. This risk is specific to medical procedures involving the kits.
Medical professionals using these kits for procedures are most at risk. Patients receiving treatments with the recalled kits could also be affected.
Check for the catalog number 45-882 on the kit packaging. The kit is sold under the brand name Bio-Stable 5F SL-55CM IR-145 with Nitinol GW PG.
Look for the catalog number 45-882 on the kit packaging to confirm if it is affected.
The recall is due to potential unsafe levels of bacterial endotoxins in the kits, which could cause health issues during medical procedures.
Check for the catalog number 45-882 on the kit packaging. The kit is labeled as Bio-Stable 5F SL-55CM IR-145 with Nitinol GW PG.
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-2192-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2192-2018 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.
