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U.S. Department of Health and Human Services

Class 2 Device Recall YelloPort Elite Universal Seal

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  Class 2 Device Recall YelloPort Elite Universal Seal see related information
Date Initiated by Firm June 02, 2022
Create Date July 18, 2022
Recall Status1 Completed
Recall Number Z-1396-2022
Recall Event ID 90447
510(K)Number K190592  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Code Information All Lots; UDI/DI:05051986001562
Recalling Firm/
Manufacturer		 Surgical Innovations Ltd
Clayton House
6 Clayton Wood Rise
Leeds United Kingdom
For Additional Information Contact Customer Service
44 0 1132307597
Manufacturer Reason
for Recall		 There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
FDA Determined
Cause 2		 Process change control
Action On June 2, 2022, Surgical Innovation issued a "urgent Field Safety Notice. On 6/8/2022, Surgical Innovations issued an "updated: Urgent Medical Device Recall notification via E-Mail to provide additional information and a revised recall strategy. The updated communication, ask consignees to take the following actions: 1.Identify the devices and quarantine all stock. 2. All product still in stock at end users must be returned to the distributor. 3. Confirmation that all such stock has been returned and that any other product has been successfully used must be obtained by the distributor. 4. The distributor shall inform Surgical Innovations of the quantities and an RMA will be provided by Surgical Innovations for return off the product to Surgical Innovations. 5. The devices shall then be returned to Surgical Innovations of disposition and the Distributor compensated for the carriage fees. 6. Replacement devices, as appropriate, which do not have this issue, will be provided by Surgical Innovations.
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, IN, WA, MA and the countries of Armenia, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Ecuador, UK, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, N. Ireland, Norway, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Dubai.
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.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = Surgical Innovations Limited
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