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U.S. Department of Health and Human Services

Class 2 Device Recall HENRY SCHEIN

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  Class 2 Device Recall HENRY SCHEIN see related information
Date Initiated by Firm November 02, 2022
Date Posted December 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0529-2023
Recall Event ID 91124
Product Classification General surgery tray - Product Code LRO
Product HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Code Information UDI/DI (case) H65857030721, UDI/DI (kit)M75257030720, Serial/Lot Numbers: 22241490953
Recalling Firm/
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
3025 Northwoods Pkwy
Peachtree Corners GA 30071-1524
For Additional Information Contact
800-886-7257
Manufacturer Reason
for Recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
FDA Determined
Cause 2
Packaging process control
Action Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Quantity in Commerce 27 units
Distribution US nationwide distribution, and Canada.
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.
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