JAGTOME RX 44-30-450-035 Material Number: M00573070
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 163 units of the JAGTOME RX 44-30-450-035 medical device (Material Number M00573070) due to a sterile barrier breach that compromises the device's sterility. The affected devices are from five specific lot numbers: 27737251, 27970819, 28289451, 27821545, and 28019275. These devices were distributed worldwide, including throughout the United States and in countries including Canada, Australia, Japan, China, and numerous European and Middle Eastern nations.
The recall notice does not specify a remedy or what actions affected consumers 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: 163 units Lot/code info: Lot Numbers: Batch 27737251 27970819 28289451 27821545 28019275 GTIN: 8714729776543
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.