Medical device recalls Moderate risk

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

Recall date
October 14, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0309-2022
FDA classification
Class II
Brand / firm
Beeken Biomedical, LLC
Sold / distributed
US in the state of MO

Why it was recalled

Endotoxin levels exceeded allowable limits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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