JAGTOME RX 49-30-450-035 Material Number: M00573030
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 14 units of the JAGTOME RX 49-30-450-035 medical device (Material Number: M00573030, GTIN: 8714729776741) from Lot Number 27951184 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 multiple countries across Europe, Asia, Africa, the Middle East, and Oceania.
The source document does not specify a remedy or recommended action for consumers who may have received an affected device.
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: 14 units Lot/code info: Lot Numbers: 27951184 GTIN: 8714729776741
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.