Recall Z-0309-2022 ยท POD Temporary, Internal Use Hemostatic
Beeken Biomedical, LLC
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
| Date | Oct 14, 2021 |
| Status | Open, Classified |
| Reason | Endotoxin levels exceeded allowable limits. |
| Root cause | Under Investigation by firm |
| Action | Beeken initiated notification via e-mail on October 14, 2021 and follow-up Urgent Medical Device Voluntary Recall Notification Letter, Certified mail dated October 20, 2021. Letter states reason for recall, health risk and action to take: Immediately check your inventory and quarantine all NuStat 8"x12" Trauma Pad XR-0812-5 Hemostatic Dressing (Lot Code: 20C015) to prevent further use. " Ensure relevant staff members, including clinicians, surgeons, OR staff and product return staff are informed of this recall. " If you have supplied any NuStat 8"x12" Trauma Pad XR-0812-5 Hemostatic Dressing ( |
| Quantity | 15 units |
| Distribution | US in the state of MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183190 | NuStat Beeken Biomedical, LLC, Sep 25, 2019 |