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U.S. Department of Health and Human Services

Class 2 Device Recall YelloPort Plus

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  Class 2 Device Recall YelloPort Plus see related information
Date Initiated by Firm January 20, 2022
Date Posted September 29, 2022
Recall Status1 Open3, Classified
Recall Number Z-1853-2022
Recall Event ID 90801
510(K)Number K070712  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Code Information Part/UDI-DI/Lot: YC0507001/05051986001890/735652
Recalling Firm/
Manufacturer		 Surgical Innovations Ltd
6 Clayton Wood Bank
Lds
Leeds United Kingdom
For Additional Information Contact Stephen Seed
44 0 1132307597
Manufacturer Reason
for Recall		 Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
FDA Determined
Cause 2		 Process control
Action On 01/20/2022, Urgent Field Safety Notices were emailed to customers who were asked to do the following: 1) Quarantine affected devices and return to the recalling firm. 2) If the devices are no longer in stock, confirm whether devices were used clinically, and if so, whether the devices were sterilized in accordance with the Instructions for Use prior to use. 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices were transferred. 4) Complete response form. The recalling firm provided the following email: quality@surginno.co.uk
Quantity in Commerce 1
Distribution US: MA
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 = GCJ and Original Applicant = SURGICAL INNOVATIONS GROUP PLC
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