Boston Scientific recalls JAGTOME RX 49-30-450-035 with a sterile barrier breach that could compromise sterility during medical procedures. Affected units have specific lot numbers and material codes.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling a specific model of JAGTOME RX device because a sterile barrier breach could compromise sterility during medical procedures. This means the device might not be safe for use in surgeries or other medical treatments where sterility is critical.
The device has a breach in its sterile barrier, which means it might not maintain the required sterile environment during medical procedures. This could lead to infections if the device is used in surgeries or other treatments where sterility is critical.
Medical professionals who use this device for procedures requiring sterile conditions. Patients undergoing surgery with this device are at risk of infection if the device is used without proper sterility.
Check for the model number JAGTOME RX 49-30-450-035 and material number M00573030. Affected units have lot numbers starting with 27951184 and GTIN 8714729776741.
Identify the model number JAGTOME RX 49-30-450-035 and material number M00573030 on the device.
No, the device has a sterile barrier breach that could compromise sterility during medical procedures, making it unsafe for use.
Check the model number and material number on the device to see if it matches the recalled items. If it does, contact Boston Scientific for further instructions.
Affected devices have the model number JAGTOME RX 49-30-450-035 and material number M00573030, with lot numbers starting with 27951184 and GTIN 8714729776741.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0779-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0779-2022 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
