Boston Scientific recalls DREAMTOME 44-30MM/450CM devices with material number M00584070 due to sterile barrier breach risking infection. Affected units have specific lot numbers and GTIN.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling DREAMTOME 44-30MM/450CM surgical devices because a sterile barrier breach could compromise sterility, potentially leading to infections. This recall affects specific lot numbers and GTINs of the product.
The device has a sterile barrier that can be breached, which may compromise sterility during medical procedures. This could lead to infections if the device is used without proper sterility.
Surgical professionals and hospitals using the DREAMTOME 44-30MM/450CM device with material number M00584070 are most at risk. The recall targets specific lot numbers and GTINs.
Check for the material number M00584070 on the device. Affected units have lot numbers 27625066 or 27805561 and GTIN 8714729778295.
Look for material number M00584070, lot numbers 27625066 or 27805561, and GTIN 8714729778295 on the device.
The device may have a sterile barrier breach, which could compromise sterility and lead to infections if used improperly.
Check for material number M00584070, lot numbers 27625066 or 27805561, and GTIN 8714729778295.
The recall does not specify a remedy, so contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0754-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0754-2022 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.
