Eight Medical recalls Recirculator 8.0s Disposable Lavage Kits (product code 8100) due to potential aluminum ion release during warming therapy. Affected units include specific lot numbers from 19854184 to 20202106.
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Eight Medical is recalling Recirculator 8.0s Disposable Lavage Kits (product code 8100) because they may release aluminum ions during warming therapy, which could expose patients to a risk. This recall affects specific lot numbers and is part of their Hyperthermic Perfusion System.
The device may release aluminum ions during warming therapy under certain conditions, which could expose patients to potential aluminum ion release. This risk is related to the Hyperthermic Perfusion System used to raise body cavity temperatures.
Patients using the Recirculator 8.0s Disposable Lavage Kit for Hyperthermic Perfusion therapy are most at risk. The recall applies to specific lot numbers produced between 19854184 and 20202106.
Check the product code number 8100 on the kit. Look for lot numbers listed: 19854184, 19854185, 19854186, 20018480, 20019438, 20021361, 20021361, 20202106, and 18687686.
Look for lot numbers on the kit: 19854184, 19854185, 19854186, 20018480, 20019438, 20021361, 20202106, and 18687686.
The product code is 8100.
Affected lot numbers include 19854184, 19854185, 19854186, 20018480, 20019438, 20021361, and 20202106.
The recall record states the remedy is null, meaning no specific action is required beyond checking the lot number.
We’ve drafted a message you can send Eight Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2005-2021 — Eight Medical Eight Medical Hello, I own a Eight Medical that is covered by recall Z-2005-2021 from Eight Medical. 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.
