Boston Scientific recalls HYDRATOME RX 49-20MM/260CM devices with material number M00583000 due to sterile barrier breach risking infection. Affected units include specific lot numbers and GTIN.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling HYDRATOME RX 49-20MM/260CM surgical devices because a sterile barrier breach could compromise sterility. This means the devices might not be safe for use in medical procedures, potentially leading to infections.
The sterile barrier in the device has been breached, which means the device may not be sterile when used. This could lead to infections during medical procedures if the device is not properly sterilized before use.
Medical professionals and hospitals that own or use the recalled HYDRATOME devices. Patients undergoing procedures with these devices are at risk of infection if the devices are used without proper sterility.
Check for the material number M00583000 on the device. Affected units include lot numbers 27852433 and 28028722, and the GTIN 8714729755159.
Verify the material number M00583000 and lot numbers 27852433 or 28028722 on the device.
The device may not be sterile due to a breach in the sterile barrier, so it should not be used without proper sterilization.
Check the material number and lot numbers to see if your device is affected; contact Boston Scientific if unsure.
Look for the material number M00583000, lot numbers 27852433 or 28028722, or GTIN 8714729755159 on the device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0763-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0763-2022 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.
