Boston Scientific recalls DREAMTOME 49-20MM/260CM devices with material number M00584000 due to sterile barrier breach compromising sterility. Affected units include specific lot numbers and GTIN.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling DREAMTOME 49-20MM/260CM devices because a sterile barrier breach could compromise sterility. This means the devices might not be safe for medical use if they are used without proper sterilization.
The device has a sterile barrier that can be breached, which means it might not be properly sterilized. If the device is used without proper sterilization, it could cause infections or other medical complications.
Medical professionals using the DREAMTOME 49-20MM/260CM device for procedures are likely affected. Patients receiving procedures with this device could be at risk if sterility is compromised.
Check the material number M00584000 on the device. Affected units have specific lot numbers: 27566791, 27604633, 27690970, 27802364, 27951185, 28028721, or GTIN 8714729778226.
Look for the material number M00584000 and specific lot numbers listed in the recall notice.
The recall is due to a sterile barrier breach that could compromise sterility, making the device unsafe for medical use without proper sterilization.
The recall notice does not specify a remedy, so contact Boston Scientific directly for guidance.
Check for the material number M00584000 and specific lot numbers: 27566791, 27604633, 27690970, 27802364, 27951185, 28028721, or GTIN 8714729778226.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0755-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0755-2022 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.
