YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Check against the official notice below — it lists the full affected range.
Surgical Innovations Ltd is recalling YelloPort Elite Universal Seals, a product used in laparoscopic procedures, due to the potential that the packaging may contain small holes that could compromise the sterility of the product. The recall affects all lots of the product distributed worldwide, including US distribution in Florida, Indiana, Washington, Massachusetts, and numerous international locations including Canada, the United Kingdom, Australia, Japan, and many European and Middle Eastern countries.
The source document does not specify a remedy or recommended action for consumers who have obtained this product.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
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. 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, Sw Quantity: N/A Lot/code info: All Lots; UDI/DI:05051986001562
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.