Boston Scientific recalls VTC Regular Kit Nephrostomy Catheter System Kit (Material REF M001245300) due to potential holes in sterile barrier pouches that could compromise device sterility.
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 nephrostomy catheter kit that may have holes in its sterile barrier pouch. This could allow contamination and infection if the kit is used without proper sterility.
The sterile barrier pouch may develop holes during manufacturing, which could allow contaminants to enter the catheter system. This risks infection if the kit is used without proper sterility checks.
Patients needing urinary drainage through a nephrostomy catheter, particularly those with recent procedures or ongoing treatments. Healthcare providers using the kit for medical procedures.
Look for the product name 'VTC Regular Kit Nephrostomy Catheter System Kit' with Material Number REF M001245300. The kit was sold with GTIN/UDI 0871472904856 and Lot # 33751204, expiring April 2027.
Verify the Material Number REF M001245300 and GTIN/UDI 0871472904856 on the kit packaging.
The recall addresses potential holes in the sterile barrier pouch that could compromise sterility, but the risk of infection is low if proper handling is followed.
Check for Material Number REF M001245300 and GTIN/UDI 0871472904856 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-3151-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3151-2024 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.
