Boston Scientific recalls specific RX Cholangiogram Kits with material numbers M00575241-M00575481 due to sterile barrier breach compromising device sterility. Affected kits may cause infection if used in medical procedures.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling specific RX Cholangiogram Kits because they have a sterile barrier breach that could compromise sterility. Using these kits during medical procedures might lead to infections if not properly sterilized.
The kits have a breach in their sterile barrier, meaning they might not be sterile when used. This could lead to infections during medical procedures if the kits are not properly sterilized after the breach.
Medical professionals using the recalled RX Cholangiogram Kits for procedures like imaging. Patients undergoing procedures with these kits may face infection risks if the kits are used without proper sterility.
Check for material numbers M00575241, M00575281, M00575321, M00575361, M00575381, M00575401, M00575441, or M00575481. Also look for specific lot numbers listed in the recall notice.
Look for material numbers M00575241 through M00575481 on the kit packaging or label.
Reach out to Boston Scientific for specific lot numbers and instructions if you have the kit.
The kits have a sterile barrier breach that could compromise sterility, potentially leading to infections during medical procedures.
Check for material numbers M00575241, M00575281, M00575321, M00575361, M00575381, M00575401, M00575441, or M00575481 on the kit packaging.
The recall indicates a potential infection risk, but the remedy is not specified, so you should check if your kit is affected before deciding to stop use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0780-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0780-2022 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.
