Beeken Biomedical, LLC Recall 88941
Description: NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Beeken Biomedical, LLC Recall 88941 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0309-2022 |
| Event ID | 88941 |
| Event Description | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5 |
| Product Type | Devices |
| Distribution | US in the state of MO |
| Quantity | 15 units |
| Recall Reason | Endotoxin levels exceeded allowable limits. |
| Device Classification | 20211208 |
| Device Code Info | Lot Code: 20C015 UDI: 00850392006544 |
| Center Classification Date | 20211126 |
| Recall Initiation Date | 20211014 |
| Recalling Firm | Beeken Biomedical, LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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