Z-0309-2022Class II

NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF...

Name: Z-0309-2022 NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF...
Creator: Beeken Biomedical, LLC
Published: 2021-10-14
License: https://open.fda.gov/license/

Beeken Biomedical LLC / initiated 2021-10-14 / Open, Classified / root cause: sterility

FDA source

Beeken Biomedical, LLC began a recall of NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5 on 2021-10-14. FDA classified it as Class II and gives the reason as "Endotoxin levels exceeded allowable limits". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0309-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-14
Posted: 2021-11-26
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
Product code: POD Temporary, Internal Use Hemostatic
Reason for recall: Endotoxin levels exceeded allowable limits.
Root cause tag: sterility
FDA 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: [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.
Quantity in commerce: 15 units
Distribution: US in the state of MO
Product codes and lots: Lot Code: 20C015 UDI: 00850392006544

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0309-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0309-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-11-26

Product code POD

K183190Class IINuStatBeeken Biomedical, LLC / cleared 2019-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)