JAGTOME RX 44-30-260-035 Material Number: M00573060
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 2,209 units of the JAGTOME RX 44-30-260-035 medical device (Material Number M00573060) due to a sterile barrier breach that compromises the sterility of the device. The recalled units were distributed worldwide, including throughout the United States and in numerous countries including Australia, Canada, China, France, Germany, Japan, and many others. The affected devices are associated with 20 specific lot numbers, ranging from Batch 27458135 through Batch 28289453.
The recall notice does not specify a remedy or corrective 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: 2209 units Lot/code info: Lot Numbers: Batch 27522394 27566792 27589267 27618168 27726335 27758466 27795807 27822419 27458135 27472063 27553565 27649356 27706277 27758465 27773622 27821544 27865086 27986549 28017367 28289453 GTIN: 8714729776673
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.