Certain lots of product have the potential for a sterile barrier breach.
Reason for recall: Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, Unit Quantity: 260 units Lot/code info: GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.
20643169454815
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.