Beeken Biomedical, LLC NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Endotoxin levels exceeded allowable limits.

Recommended Action

Per FDA guidance

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: rkendall@beekenbiomedical.com 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.

Distribution

As reported by FDA

IN, MO