YelloPort Elite Universal Seal. For use in laparoscopic recall: Sterility Concern
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Why was YelloPort Elite Universal Seal. For use in laparoscopic recalled?
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots; UDI/DI:05051986001562
- Product
- YelloPort Elite Universal Seal. For use in laparoscopic procedures.
- Recalling firm
- Surgical Innovations Ltd
- Quantity
- N/A
- 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.
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)