Boston Scientific recalls a sump catheter kit with potential sterile barrier holes that could compromise device sterility. Affected units 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 a sump catheter system kit due to potential holes in the sterile barrier pouch. This could compromise sterility during medical procedures, risking infection or other complications for patients.
The sterile barrier pouch could develop holes during use, potentially allowing contaminants to enter the catheter system. This might compromise sterility and increase infection risk during medical procedures.
Patients receiving this catheter kit for abdominal fluid drainage are most at risk. Healthcare providers using the kit for medical procedures may also be affected.
Check for the material number REF M001273090 on the kit packaging. The kit was sold with expiration date 02/26/2027 and lot number 33512377.
Look for the material number REF M001273090 on the kit packaging to confirm if it's affected.
The recall is for potential sterile barrier holes that could compromise sterility, but the hazard level is low risk as the remedy is not immediate stop-use.
Check for material number REF M001273090 on the packaging. The kit was sold with expiration date 02/26/2027 and lot number 33512377.
The recall does not specify a remedy, so check with Boston Scientific for guidance if you have the kit.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3150-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3150-2024 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.
