JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 7,115 units of the JAGTOME REVOLUTION RX 39-20-260-025 device (Material Number M00584240) 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 such as Australia, Canada, China, France, Germany, Japan, South Africa, and many others. The recall involves 17 specific lot numbers ranging from 27481920 to 28070708.
The recall record does not specify a remedy for affected consumers or what actions they should take.
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: 7115 units Lot/code info: Lot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.