---
title: "NuStat 8\" x12\" Trauma Pad XR Hemafiber, 5-pack. For temporary control of inte... — FDA record Z-0309-2022 | Is It on Recall"
description: "Endotoxin levels exceeded allowable limits."
url: https://isitonrecall.com/recall/fda-device-z-0309-2022-nustat-8-x12-trauma-pad-xr-hemafiber-5-pack-for-temporary-control-of-internal-organ-space-bleeding-r/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5 — FDA record Z-0309-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
- **Reason**: Endotoxin levels exceeded allowable limits.
- **Classification**: Class II
- **Recalling firm**: Beeken Biomedical, LLC
- **Quantity**: 15 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0309-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0309-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Code: 20C015 UDI: 00850392006544 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US in the state of MO

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Missouri](https://isitonrecall.com/state/missouri/)

## Dates in the source

- **Report date**: Dec 8, 2021
- **Recall initiation date**: Oct 14, 2021
- **Center classification date**: Nov 26, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0309-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Beeken Biomedical, LLC records](https://isitonrecall.com/brand/beeken-biomedical-llc/)