JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 68 units of the JAGTOME REVOLUTION RX 39-20-450-025 medical device (Material Number M00584250, Lot Number 27482864) due to a sterile barrier breach that compromises the device's sterility. The affected devices were distributed worldwide, including throughout the United States and in countries including Australia, Canada, China, France, Germany, Great Britain, Japan, and many others.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Sterility of device is compromised due to a sterile barrier breach
Reason for recall: Sterility of device is compromised due to a sterile barrier breach Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa Quantity: 68 units Lot/code info: Lot Numbers: 27482864 GTIN: 8714729953241
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.