JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 3,330 units of the JAGTOME REVOLUTION RX 39-30-260-025 medical device (Material Number M00584260) due to a sterile barrier breach that compromises the sterility of the device. The affected units were distributed worldwide, including throughout the United States and in countries such as Canada, Australia, Japan, China, and numerous European nations. The recall involves specific lot numbers ranging from Batch 27482863 through Batch 28021411.
The recall notice does not specify a remedy or course of 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: 3330 units Lot/code info: Lot Numbers: Batch 27482863 27532553 27602969 27652583 27723139 27758892 27796835 27846707 27899139 27966498 28021411 GTIN: 8714729953258
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.