Boston Scientific recalls RX Cholangiogram Kits with specific material numbers due to sterile barrier breaches compromising device sterility. Affected kits may not be safe for medical procedures.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling RX Cholangiogram Kits with certain material numbers because the sterile barrier has been breached, which could compromise the sterility of the device. This means the kits might not be safe for medical procedures if used without proper sterilization.
The sterile barrier in the kit has been breached, which means the device may not be sterile when used. This could lead to infections or other complications during medical procedures if the kit is not properly sterilized.
Healthcare professionals who use these kits for medical imaging procedures are most at risk. Patients receiving these kits could be affected if the sterility is compromised.
Check for the material numbers listed: M00575240, M00575280, M00575320, M00575360, M00575380, M00575400, M00575440, M00575480. These kits were sold with specific lot numbers and unique device identifiers.
Identify the material numbers on your kit to see if they match the listed numbers: M00575240, M00575280, M00575320, M00575360, M00575380, M00575400, M00575440, M00575480.
Reach out to Boston Scientific for specific instructions on how to handle the recalled kits if you have them.
The sterile barrier in the kit has been breached, which could compromise the sterility of the device and lead to infections during medical procedures.
The affected material numbers are M00575240, M00575280, M00575320, M00575360, M00575380, M00575400, M00575440, and M00575480.
Check the material numbers on your kit against the list: M00575240, M00575280, M00575320, M00575360, M00575380, M00575400, M00575440, M00575480.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0781-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0781-2022 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.
