JAGTOME RX 39-20-450-025 Material Number: M00573090
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 367 units of the JAGTOME RX 39-20-450-025 medical device (Material Number: M00573090) 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 countries such as Australia, Canada, China, France, Germany, Japan, the United Kingdom, and numerous others. The recalled units are from Lot Numbers Batch 27632862 and 27855805.
The record does not specify a remedy or recommended action for consumers who may have this product.
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: 367 units Lot/code info: Lot Numbers: Batch 27632862 27855805 GTIN: 8714729776550
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.