Angiodynamics recalls Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG (Catalog 45-887) due to potential unsafe bacterial endotoxins. Affected units include specific lot numbers and UPC.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics is recalling a specific medical kit for possible unsafe levels of bacterial endotoxins. This could pose a health risk if used in medical procedures.
The kit might contain unsafe levels of bacterial endotoxins, which can cause fever or other infections if introduced into the body during medical procedures. This is a potential risk in sterile medical environments.
Healthcare professionals using the Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG (Catalog 45-887) are most at risk. Patients receiving procedures with this kit may also be affected.
Check for the Catalog Number 45-887 on the kit. Affected units include specific lot numbers and UPC: H965458870 and Lot: 5305574.
Look for the Catalog Number 45-887 and lot numbers H965458870 and 5305574 on the kit.
The recall states there might be unsafe levels of bacterial endotoxins, which could cause fever or infection during medical procedures. However, the risk level is considered low.
Check for the Catalog Number 45-887 and lot numbers H965458870 and 5305574 on the kit.
The recall does not specify a remedy, so no action is required beyond checking if you have the kit.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2194-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2194-2018 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.
