JAGTOME RX 49-20-260-035 Material Number: M00573000
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 101 units of the JAGTOME RX 49-20-260-035 device (Material Number M00573000) due to a sterile barrier breach that compromises the sterility of the device. The affected units were distributed worldwide, including throughout the United States and in 32 other countries including Canada, Japan, Australia, and various European nations. The recalled lot numbers are 27690967, 27949032, 27604634, and 27692921.
The source document does not specify a remedy or what actions affected consumers should take in response to this recall.
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: 101 units Lot/code info: Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.