Boston Scientific recalls HYDRATOME RX 44-20MM/450CM surgical devices with a sterile barrier breach. This compromises sterility and may lead to infections during 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 HYDRATOME RX 44-20MM/450CM surgical devices because a sterile barrier breach risks infection. This is serious for medical procedures where sterility is critical.
The sterile barrier breach means the device may not be sterile when used. This can lead to infections during medical procedures if the device is used without proper sterilization.
Surgical professionals and hospitals using the HYDRATOME RX 44-20MM/450CM devices with the specified lot numbers and material code. Patients undergoing procedures with these devices are at risk of infection.
Check for the material number M00583060 and lot numbers Batch 27442309 or 28020415 on the device. The GTIN 8714729755210 is also associated with these units.
Verify the material number M00583060 and lot numbers Batch 27442309 or 28020415 on the device.
No, the sterile barrier breach means the device may not be sterile, increasing infection risk during procedures.
Check the device for the material number M00583060 and lot numbers Batch 27442309 or 28020415. If affected, contact Boston Scientific for guidance.
Look for the material number M00583060 and lot numbers Batch 27442309 or 28020415 on the device. The GTIN 8714729755210 is also associated with these units.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0760-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0760-2022 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.
