FDA Medical Device Recalls (openFDA)
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 number
- Z-0309-2022
- Recalling firm
- Beeken Biomedical, LLC
- Product
- NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
- Status
- Open, Classified
- Initiated
- 2021-10-14
- Posted
- not on file
- Terminated
- not on file
- 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 (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.
- Quantity
- 15 units
- Distribution
- US in the state of MO
- Lot, serial or model codes
- Lot Code: 20C015 UDI: 00850392006544
- 510(k) numbers
- ["K183190"]
- PMA numbers
- not on file
- Product code
- POD
- Firm FEI
- 3009348684
- Firm city
- Stoughton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28