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U.S. Department of Health and Human Services

Class 2 Device Recall Stradis

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  Class 2 Device Recall Stradis see related information
Date Initiated by Firm September 10, 2021
Create Date October 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0130-2022
Recall Event ID 88656
510(K)Number K073182  
Product Classification Tenaculum, uterine - Product Code HDC
Product Foundation Kit
Code Information Part Number: A10
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		 Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
FDA Determined
Cause 2		 Device Design
Action The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
Quantity in Commerce 790 kits
Distribution Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to 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.
510(K) Database 510(K)s with Product Code = HDC and Original Applicant = GYN-DISPOSABLES, INC.
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