Device product
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Z-1396-2022
Product summary
- Event
- Event 90447
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1396-2022
Official wording
Reason: There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Code information: All Lots; UDI/DI:05051986001562
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.