Boston Scientific recalls JAGTOME RX 39-30-450-025 with a sterile barrier breach risk. Affected units have specific lot numbers and material codes. Stop using immediately to prevent infection.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling a specific JAGTOME RX device model due to a sterile barrier breach that could compromise sterility. This risk means the device might not be safe for medical procedures if used without proper sterilization.
The sterile barrier in the device has been breached, meaning the device might not be properly sterilized. This could lead to infections during medical procedures if the device is used without adequate sterilization.
Medical professionals using the JAGTOME RX 39-30-450-025 device with the specified lot numbers and material code are affected. Patients receiving procedures with this device face the highest risk of infection.
Check for the model number JAGTOME RX 39-30-450-025 and material number M00573110. Affected units have lot numbers starting with 27857328 and GTIN 8714729776529.
Discard the device if you have it to prevent infection risk.
No, the device has a sterile barrier breach that could compromise sterility, so it should not be used.
Lot numbers starting with 27857328 are affected.
Check for model number JAGTOME RX 39-30-450-025 and material number M00573110, and verify the lot number starts with 27857328.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0772-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0772-2022 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.
