JAGTOME RX 44-20-450-035 Material Number: M00573050
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 3,578 units of the JAGTOME RX 44-20-450-035 device (Material Number M00573050) distributed worldwide, including throughout the United States and 32 other countries. The recall was initiated because the sterility of the device is compromised due to a sterile barrier breach. The affected lot numbers are 27535120, 27643043, 27730949, 27836207, 27571950, 27591704, 27625065, and 27773387.
The recall notice 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: 3578 units Lot/code info: Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.