Boston Scientific recalls HYDRATOME RX 49-30MM/260CM devices due to sterile barrier breach risking infection. 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 49-30MM/260CM surgical devices because a sterile barrier breach could compromise sterility. This risk of infection means affected devices should not be used until corrected.
A sterile barrier breach in the device could allow contamination, leading to infection during medical procedures. This is a risk to sterility but does not cause immediate injury or death.
Surgical device users and hospitals that own the recalled HYDRATOME RX 49-30MM/260CM devices with specific lot numbers. Patients using these devices during procedures are at risk of infection.
Check for the model name 'HYDRATOME RX 49-30MM/260CM' and material number M00583010. Affected units have lot numbers 27641142 or 28045346.
Identify the model name, material number, and lot numbers to confirm if your device is affected.
The recall is due to a sterile barrier breach that could compromise sterility, risking infection during medical procedures.
Check the device details against the listed lot numbers and material number to confirm if it's affected. If affected, contact Boston Scientific for further instructions.
The device is not dangerous if used correctly, but the recall indicates a potential sterility risk that requires verification.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0764-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0764-2022 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.
