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U.S. Department of Health and Human Services

Class 2 Device Recall Beekan

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  Class 2 Device Recall Beekan see related information
Date Initiated by Firm October 14, 2021
Create Date November 26, 2021
Recall Status1 Open3, Classified
Recall Number Z-0309-2022
Recall Event ID 88941
510(K)Number K183190  
Product Classification Temporary, internal use hemostatic - Product Code POD
Product NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding
REF: XR-0812-5
Code Information Lot Code: 20C015 UDI: 00850392006544
Recalling Firm/
Manufacturer		 Beeken Biomedical, LLC
378 Page St Ste 201
Stoughton MA 02072-1124
For Additional Information Contact SAME
508-274-5510
Manufacturer Reason
for Recall		 Endotoxin levels exceeded allowable limits.
FDA Determined
Cause 2		 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 in Commerce 15 units
Distribution US in the state of MO
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = POD and Original Applicant = Beeken Biomedical, LLC
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