Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.
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.