# FDA recall Z-0309-2022

> **Beeken Biomedical, LLC** · Class II · device recall initiated 2021-10-14.

## Product

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

## Reason for recall

Endotoxin levels exceeded allowable limits.

## Distribution

US in the state of MO

## Key facts

- **Recall number:** Z-0309-2022
- **Recalling firm:** Beeken Biomedical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-14
- **Report date:** 2021-12-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stoughton, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0309-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0309-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*