Reported Dec 8, 2021 · Ongoing

NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

Beeken Biomedical, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beeken Biomedical, LLC · 378 Page St Ste 201 · Stoughton, MA · 02072-1124

Is this the product you have?

    • NuStat 8" x12" Trauma Pad XR Hemafiber
    • 5-pack. For temporary control
  • of internal organ space bleeding REFXR-0812-5
Lot codes and dates
  • Lot Code20C015
  • UDI00850392006544
Amount recalled
15 units

Where it was sold

Why it was recalled

Endotoxin levels exceeded allowable limits.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

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