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Boston Scientific Corporation recalls NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/21
Recalled July 17, 2013 · FDA recall Z-1672-2013 · Boston Scientific
Hazard
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. · FDA Class II
Units
27
Sold at
Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
Description
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Product
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →