Boston Scientific recalls Flexima Regular Kit Biliary Catheter Systems due to potential holes in sterile pouches that could compromise device sterility. Affected kits have specific material numbers and expiration dates.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Boston Scientific is recalling Flexima Regular Kit Biliary Catheter Systems because the sterile pouches might develop holes, risking contamination. This could lead to infections if the catheter is used without proper sterility.
The sterile pouches in the kit could develop small holes, which might allow contaminants to enter the catheter system. This could compromise sterility and increase infection risk during medical procedures.
Patients receiving bile drainage catheters through this kit are most at risk. Healthcare providers using the kit for medical procedures may also be affected.
Check for material number REF M001271650 on the kit. The kit expires February 26, 2027, and has lot number 33512376.
Look for material number REF M001271650 and expiration date February 26, 2027 on the kit packaging.
The recall addresses a potential risk of holes in the sterile pouch that could compromise sterility, but it does not indicate a risk of serious injury or death in normal use.
Check for material number REF M001271650 and expiration date February 26, 2027 on the kit packaging.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3148-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3148-2024 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.
