NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For… recallZ-0309-2022 · Beeken Biomedical, LLC · initiated Oct 14, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beeken Biomedical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Endotoxin levels exceeded allowable limits.
FDA root cause category: Under Investigation by firm
What the company is doing
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 (Lot Code: 20C015) to any other organization or clinical site, please advise that organization of this recall and notify Beeken Biomedical of that organization's name, address, and contact person so that we may contact them immediately. " Please immediately complete the attached Acknowledgement form - even if you have none of this product- and return the form to Beeken Biomedical by email to: [email protected] or by mail to Recall Administrator Beeken Biomedical, LLC 378 Page Street, Suite 201 Stoughton, MA 02072 questions about this recall, please email or phone Beeken Biomedical Customer Service at 888-497-7376, Monday through Friday, between the hours of 8:30 am and 4:00 pm (EST) or otherwise leave a message which will be returned on the next working day.
Recall details
- Recall number
- Z-0309-2022
- Status
- Open, Classified
- Initiated by the company
- Oct 14, 2021
- Recalling firm
- Beeken Biomedical, LLC
- Quantity
- 15 units
- Product code
- POD
- FDA submissions
- K183190
- Distribution
- US in the state of MO
Product description
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Code information (models, lots, serial numbers)
Lot Code: 20C015 UDI: 00850392006544
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NuStat Trauma Pad XR XR-0812-5Beeken Biomedical LLC · Dressing, Wound, Drug1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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