JAGTOME RX 39-20-260-025 Material Number: M00573080
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 4,487 units of the JAGTOME RX 39-20-260-025 medical device (Material Number: M00573080) due to a sterile barrier breach that has compromised 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 many others. The recall involves ten specific lot numbers: 27505913, 27563424, 27629942, 27731957, 27755861, 27839657, 27846391, 27986551, 27991931, and 28036372.
The product recall record does not specify a remedy or what actions an affected consumer should take.
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: 4487 units Lot/code info: Lot Numbers: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.