FDA-Device2021-12-08Class II

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

Beeken Biomedical, LLC
Hazard

Endotoxin levels exceeded allowable limits.

Sold states
US in the state of MO
Affected count
15 units
Manufactured in
378 Page St Ste 201, Stoughton, MA, United States
Products
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0309-2022

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