Beeken Biomedical recalls 5-pack NuStat 8"x12" Trauma Pads XR Hemafiber due to endotoxin levels exceeding safety limits for internal bleeding control.
Endotoxin levels exceeded allowable limits.
Beeken Biomedical is recalling 5-pack NuStat 8" x 12" Trauma Pad XR Hemafiber products because they contain endotoxin levels that exceed safe limits for temporary internal bleeding control. This could pose a health risk if used improperly.
The trauma pads contain endotoxin levels that exceed allowable limits. Endotoxins are bacterial components that can cause health issues when introduced into the body, particularly in medical applications where internal bleeding is being controlled.
Users of these trauma pads for internal bleeding control are affected. Medical professionals and emergency responders who use the product are most at risk.
Check for the product name 'NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack' with lot code 20C015 and UDI 00850 0392006544. These were sold with reference number XR-0812-5.
Verify the lot code (20C015) and UDI (00850392006544) on the product packaging.
The recall states endotoxin levels exceeded allowable limits, so the product is not safe for use as intended.
The recall record does not specify a remedy, so no action is required beyond checking product details.
Look for lot code 20C015 and UDI 00850392006544 on the packaging, which identifies the specific batch of the 5-pack NuStat Trauma Pads.
We’ve drafted a message you can send Beeken Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0309-2022 — Beeken Biomedical Beeken Biomedical Hello, I own a Beeken Biomedical that is covered by recall Z-0309-2022 from Beeken Biomedical. 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.
