The Recall Desk
HighFDA (Devices)·Z-0309-2022·Announced 2021-12-08

NuStat Trauma Pad XR Hemafiber Recalled for Elevated Endotoxin Levels

Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification applies. No hospitalization or injury is reported, so the Class II hospitalization criterion for Score 4 does not apply. Endotoxin contamination in a sterile internal-use medical device is a risk-of-harm product where injury has not yet been reported, meeting the High (3) severity criterion.

Plain-English summary

Beeken Biomedical, LLC is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber, a sterile medical device designed for temporary control of internal organ space bleeding. The product is sold in 5-packs under lot code 20C015.

The recall was initiated because endotoxin levels in the product exceeded allowable limits. Elevated endotoxin in a sterile internal-use medical device poses a potential risk of bacterial contamination.

This recall affects 15 units that were distributed in Missouri.

The recalled product

Product
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Manufacturer
Beeken Biomedical, LLC
Category
Medical Device — Trauma / Wound Care
Hazard
  • endotoxin

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: 20C015 UDI: 00850392006544

Distribution

Distributed in 1 state:

  • MO

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