FDAFDA · Food and drugs·Recall number Z-1672-2013
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Published July 17, 2013 · Recall initiated: May 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
- Lot
- Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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