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FDA (Device enforcement)Recalled 2021-12-22class ii

Boston Scientific Corporation: JAGTOME RX 39-30-260-025 Material Number: M00573100

Is my product affected?

JAGTOME RX 39-30-260-025 Material Number: M00573100

  • UPC 8714729776536

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation has recalled 1,447 units of the JAGTOME RX 39-30-260-025 medical device (Material Number M00573100) 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 many others. The recall involves eight specific lot numbers: 27465196, 27566099, 27603464, 27641141, 27731956, 27855806, 27998506, and 28297081.

The source document does not specify a remedy for consumers or affected patients who have this device.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Sterility of device is compromised due to a sterile barrier breach

Details from the source

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: 1447 units Lot/code info: Lot Numbers: 27465196 27566099 27603464 27641141 27731956 27855806 27998506 28297081 GTIN: 8714729776536

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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