FDA Device recall Z-0309-2022
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack
- FDA Device
- Class II
- ongoing
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack by Beeken Biomedical, citing endotoxin levels exceeded allowable limits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0309-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-14 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beeken Biomedical |
| Distribution | MO |
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.
Identifiers
| code_info | Lot Code: 20C015 UDI: 00850392006544 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.