| Class 2 Device Recall STRADIS HEALTHCARE | |
Date Initiated by Firm | November 02, 2022 |
Date Posted | December 14, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0544-2023 |
Recall Event ID |
91124 |
Product Classification |
Angiography/angioplasty kit - Product Code OEQ
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Product | STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, |
Code Information |
UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509 |
Recalling Firm/ Manufacturer |
Stradis Medical, LLC dba Stradis Healthcare 3025 Northwoods Pkwy Peachtree Corners GA 30071-1524
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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 | 100 units |
Distribution | US nationwide distribution, and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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