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Recall Observatory FDA recall evidence

Device product

YelloPort Elite Universal Seal. For use in laparoscopic procedures.

Z-1396-2022

June 02, 2022

Class II

Product summary

Firm
Surgical Innovations Ltd
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

    reason.no_named_rule · v1.0.0

    There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.