JAGTOME RX 49-30-260-035 Material Number: M00573020
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 96 units of the JAGTOME RX 49-30-260-035 device (Material Number: M00573020, Lot Number 27571949) distributed worldwide to the United States and 32 other countries including Australia, Canada, Japan, and most of Europe. The recall was initiated because the sterile barrier of the device has been breached, which compromises its sterility.
The record does not specify a remedy or what affected consumers should do 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: 96 units Lot/code info: Lot Numbers: 27571949 GTIN: 8714729776734
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.